Appendix Summary of the Evidence

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					Appendix 5.3 – Summary of the Evidence

Citation                                       Level &   Study Design & Sample        Intervention & Outcomes               Results                                                    Comments
                                               Quality
Ahmed KA, Samant S, Vieira F.                  III-2 Ø   Comparative study with       G tube inserted by surgical           Pt characteristics more likely to require a PEG: T4.
Gastrostomy tubes in patients with advanced              concurrent controls, USA     endoscopy/ Gastroenterology based
head and neck cancer. Laryngoscope                                                    on clinical judgment, (mean=day 20)   Pt characteristics less likely to require a PEG: T2,
                                                         N=477                                                              Larynx & paranasal sinus.
2005;115:44-7.
                                                                                      N=220 required a PEG
                                                         Previously untreated Stage                                         Nodal disease not significant.
                                                         III& IV SCC H&N              Outcomes:
                                                         undergoing CRT.              PEG placement, Wt, mucositis,         Highest OR of requiring G tube: hypopharynx, oral
                                                                                      nausea                                cavity & oropharynx# (#45% of all tubes).

                                                                                                                            No diff in reported nausea/ mucositis, mean wt loss very
                                                                                                                            similar between groups.

Akst LM, Chan J, Elson P, Saxton J, Strome     IV +      HNC patients having CRT      Need for TF                           76% had TF at end of treatment (31% pro)                   Inadequate data for full
M, Adelstein D. Functional outcomes                      from 1989-2002               R/V at 3, 6, 12, 24 month post        77% still TF 3/12                                          sample.
following chemoradiotherapy for head and                 N=202 (included 196)         treatment                             8% TF at 12/12
                                                                                                                            6% TF at 24/12
neck cancer. Otolaryngol Head Neck Surg
                                                                                                                            Best improvement seen between 3-6mth
2004;131:950-7.                                                                                                             Little improvement between 12-24mth
                                                                                                                            Those with stage 4 had increased TF dependence

Allen AM, Elshaikh M, Worden FP, et al.        IV Ø      Case series, USA             Accelerated CRT protocol.             •   Late grade III pharyngeal toxicity 15% pts             Results however are of
Acceleration of hyperfractionated                                                                                           •   Local/regional and distant failure rates were 28%      limited use except to confirm
chemoradiation regimen for advanced head                 N=46                         All patients in whom the pharynx          and 17%                                                high incidence of acute
                                                                                      was included in the high-dose         •   52% are alive without evidence of disease              mucositis and dysphagia and
and neck cancer. Head Neck 2007;29:137-
                                                         Pts with unresectable        treatment volumes (n=42) were                                                                    some late dysphagia.
42.                                                      local/regional disease       referred for PEG at the start of      •   Median weight change relative to baseline in all
                                                         treated with                 treatment. Only 22 had PEG (52%).         patients was ↓6.2% (range, ↓32.9% to↑11.2%).           Time points for survival data
                                                         hyperfractionated,                                                 •   Median weight change during therapy in patients        missing.
                                                         concurrent chemoradiation    Patients were assessed weekly and         with and without enteral feeding tubes was ↓3.8%
                                                         regimen for advanced         following treatment every 6 to 8          and ↓7.9%, respectively p=0.08.                        Recommended PEG did not
                                                         head and neck SCC.           weeks during the first 2 years and                                                               occur in 20 of the 42pts due
                                                                                                                            •   Primary late complication was strictures and late
                                                                                      every 3 months thereafter for acute                                                              to patient refusal or need to
                                                                                                                                dysphagia. Strictures requiring dilation occurred in
                                                                                      and late toxicity.                                                                               start therapy before a PEG
                                                                                                                                15% of the patients.
                                                                                                                                                                                       could be placed.
                                                                                                                            •   Of the patients without prophylactic PEG (n=20), 9
                                                                                      Outcomes:
                                                                                                                                received PEG during treatment and 5 had PEG
                                                                                      • Disease progression                                                                            Late referral to speech -
                                                                                                                                within 3 weeks post treatment for progressive
                                                                                      • Survival duration                                                                              Patients with dysphagia >3
                                                                                                                                dysphagia and weight loss.
                                                                                      • Toxicity                                                                                       months post therapy.
                                                                                      • Tube feeding
                                                                                      • Weight change

Amann W, Mischinger HJ, Berger A, et al.       III-2 -   Retrospective database       PEG insertion                         Complication rate = 9.91%                                  Limits of BMI used as
Percutaneous endoscopic gastrostomy                      comparative cohort,                                                Severe complications (surgical intervention required) =    indicator of nutritional status.
(PEG). 8 years of clinical experience in 232             Austria                      Baseline: BMI, cholesterol, TG,       5.17%
                                                                                      protein levels                        BMI lower in tumour patients compared to benign
patients. Surg Endosc 1997;11:741-4.
                                                         N=230                                                              disease p<0.001
                                                                                      Monitored: Complications post PEG     BMI lower in patients with complications compared to
                                                         Malignant disease vs.                                              those having no complications p=0.0066
                                                         benign disease                                                     No difference in cholesterol, TG or protein levels
Citation                                      Level &   Study Design & Sample        Intervention & Outcomes                Results                                                     Comments
                                              Quality
Ames JA, Karnell LH, Gupta AK, et al.         IV Ø      Retrospective cohort,        Intervention: H&N Ca Treatment         A majority of patients had some continued oral intake       Results indicated that
Outcomes after the use of gastrostomy tubes             Iowa                         including RTx requiring gastrostomy    while receiving radiation therapy, with 52.7% receiving     continued oral intake was
in patients whose head and neck cancer was                                           tube insertion.                        less than half and 5.5% receiving more than half of their   associated with significantly
                                                        N=91                                                                nutritional intake orally, whereas 39.6% had no oral        better survival (p = 0.008) in
managed with radiation therapy. Head &
                                                                                     Outcomes:                              intake.                                                     a multivariate analysis that
Neck 2010;33:638-44.                                    Patients who received a G    • Weight change                                                                                    included age and stage.
                                                        tube while their H&N Ca      • Type of diet and patient reported    Patients with no oral intake were also more likely to
                                                        was being treated with         eating function                      have advanced stage disease, laryngeal tumors, and          Pretreatment placement was
                                                        RTx @ the University of      • Mucositis (most severe during        multimodality therapy, although the differences were not    not routine during the time
                                                        Iowa Hospitals & Clinics       treatment)                           significant.                                                frame of this study. Instead,
                                                        between January 2001 and     • Continued oral intake (proportion                                                                patients who had pre-
                                                        April 2007 and who were        of daily nutritional input: none,    Patients with some oral intake also had shorter durations   treatment swallowing
                                                        enrolled in the institutes     <50%, >50%)                          of gastrostomy tube placement, 228 days compared with       problems or a heavier burden
                                                        longitudinal outcomes        • Tube type, timing of placement       314 days for those with no oral intake.                     of comorbid illness were the
                                                        assessment project.            (pre-treatment, early (<12 weeks                                                                 ones most likely to receive a
                                                                                       from start of Tx), and late (>12     Patients who lost more than 15% of their weight and         gastrostomy tube before the
                                                                                       weeks after starting Tx)) and        patients who reported lower eating scores had longer        initiation of radiation therapy.
                                                                                       timing of tube removal               gastrostomy tube durations compared with their              It is, therefore, likely that
                                                                                                                            counterparts.                                               pretreatment placement for a
                                                                                                                                                                                        substantial percentage of
                                                                                                                            No discernible trend was seen in the duration of            these patients represented
                                                                                                                            gastrostomy tube placement for the different types of       poor functioning at
                                                                                                                            diets.                                                      presentation, and that such
                                                                                                                                                                                        poor functioning before
                                                                                                                            Observed survival analyses performed on all patients        treatment was the reason for
                                                                                                                            indicated that the group with continued oral intake had     the lack of any oral intake
                                                                                                                            significantly better survival than those with no oral       during treatment.
                                                                                                                            intake (p < .001).

                                                                                                                            When grouped into 4 age categories (based on patient
                                                                                                                            sample quartiles) survival decreased as age increased,
                                                                                                                            from 5-year rates of 73.3% among individuals 48 years
                                                                                                                            or younger, to 35.4% among individuals 62 years and
                                                                                                                            older. Survival was also lower in individuals with stage
                                                                                                                            4 disease (51.0%) compared to those with stage 1 to 3
                                                                                                                            disease (65.4%).

Anwander T, Berge S, Appel T, et al.          III-2 Ø   Prospective non-             1. Prophylactic PEG with feeding       Control group                                               Gender difference: higher %
Percutaneous endoscopic gastrostomy for                 randomised cohort study,     during pre-op CRT and post surgery.    •    Lost more weight -NS                                   women had PEGs, more men
long-term feeding of patients with                      Germany                      Vs                                     •    Decrease in TSF p<0.001                                refused PEG.
                                                                                     2. No prophylactic PEG (refused):      •    No difference in MAC -NS
oropharyngeal tumors. Nutr Cancer
                                                        N=30                         exclusive oral diet during pre-op
2004;50:40-5.                                                                        CRT, and post-op N/G feeds
                                                        >T2 oropharyngeal
                                                        undergoing pre-op CRT,       Outcomes:
                                                        then radical tumour          Wt change, triceps skinfold, mid-arm
                                                        surgery                      circumference, lab tests.

                                                                                     Measured at hospitalisation, time of
                                                                                     PEG placement /equivalent, after RT,
                                                                                     3/7 post-op, 3/52 post-op.
Citation                                       Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                    Comments
                                               Quality
Arnold C, Richter MP. The effect of oral       II Ø      RCT, USA                    Control (C) Grp =Ad lib diet &          •   NSD weight loss , side effects, treatment              More than 20yrs since
nutritional supplements on head and neck                                             intensive nutritional counseling.           interruptions, survival at 3/12                        publication therefore
cancer. Int J Radiat Oncol Biol Phys                     N=50                        Oral nutrition supplements (ONS)        •   Mean energy intake ONS > C p=0.035                     treatment protocols etc
                                                                                     Grp = as above plus 960-1080kcal/d      •   Mean protein intake ONS > C p=0.005                    changed ++.
1989;16:1595-9.
                                                         H&N cancer pts receiving    Sustacal liquid for 10wks from day 1    •   ONS maintained albumin during and post RT and          Compliance was reported
                                                         definitive RT.              of RT.                                      ONS >C at 6mths                                        and discussed.
                                                                                     Reviewed weekly + six months            •   Mean consumption of ONS as % of recommended
                                                                                     follow up                                   amount (females 56%, males 67%).
                                                                                     Time points:                            •   None received tube feeds in first 10wks – 2 from
                                                                                     •     Nutr Assessment = Pre-                each group at 6mths
                                                                                           treatment, 3,5,7,10wks and        •   Weight loss continued after RT completed (~7lb)
                                                                                           6mths
                                                                                     •     Radiation side effects=weekly
                                                                                           during RT
                                                                                     •     Tumour status = 3-4mths post
                                                                                     Outcomes:
                                                                                     •     Body weight
                                                                                     •     Serum albumin, transferrin
                                                                                     •     Total Energy & protein intake
                                                                                           from diet and ONS
Aswani J, Thandar M, Otiti J, Fagan J. Early   III-3 Ø   Cohort study with           Intervention group (n=40): early oral   Pharyngocutaneous fistulae (NS):
oral feeding following total laryngectomy. J             historical control, South   feeding -                               Early: 20%; Late: 15.4%
Laryngol Otol 2009;123:333-8.                            Africa                      Day 0 - IV General Maintenance
                                                                                     Solution                                Time to fistula diagnosis (NS):
                                                         N=79                        Day 1 - IV General Maintenance          Early: day 11; Late: day 14
                                                                                     Solution & stomagastric feeds
                                                         Advanced SCC larynx         Day 2 - Clear fluids & stomagastric     LOS (median) (NS):
                                                         undergoing a                feeds                                   Early: 14 days; Late: 13 days
                                                         laryngectomy.               Day 3 - Free fluids
                                                                                     Day 4 - Soft diet                       LOS for patients who did not develop fistulae
                                                                                     Day 5 - Normal diet                     (p=0.007):
                                                                                     Control group (n=39): late oral         Early: 10.5 days; Late: 14 days
                                                                                     feeding
                                                                                     Outcomes: Fistula, LOS
Avery C, Shenoy S, Shetty S, Siegmund C,       IV Ø      Case series, UK             PEG insertion by maxillofacial          97% successful insertion -median procedure time 10 min
Mazhar I, Taub N. The prospective                                                    surgeon.                                75% (169/225) of insertion procedures post
experience of a maxillofacial surgeon with               N=206                                                               tracheostomy during definitive surgery.
                                                                                     Outcomes:                               Minor complication rate 12% (26/225).
the percutaneous endoscopic gastrostomy
                                                         Patients with a head and    •    Timing of insertion and            Major complication rate 3% (7/225).
technique. Int J Oral Maxillofac Surg                    neck malignancy requiring        removal                            No procedure related mortality. Overall 30 day mortality
2008;37:140-8.                                           PEG insertion.              •    Duration of the procedure          rate 6% (14/225).
                                                                                     •    Major and minor complications      An increased risk of death was associated with:
                                                                                     •    Association of surgical            •     Age >65 years p=0.004
                                                                                          procedure, radiotherapy +          Median PEG duration was 337 days. Associated with:
                                                                                          chemotherapy to duration of        •     T3-T4 p=0.028
                                                                                          PEG use                            •     >N1 p=0.034
                                                                                                                             •     Surg + post op RT p<0.001
                                                                                                                             •     Glossectomy p=0.038
                                                                                                                             •     Maxillectomy p=0.003
                                                                                                                             •     2 surgical procedures + RT p=0.046
                                                                                                                             •     Post bone resection p=0.031
                                                                                                                             •     RT compared to Surgery p=0.003
                                                                                                                             •     No difference for age
Citation                                        Level &   Study Design & Sample       Intervention & Outcomes                Results                                                     Comments
                                                Quality
Bahl M, Siu LL, Pond GR, et al. Tolerability    IV +      Case series, Canada         Median follow up = 16.2mths post       Compliance with treatment – 73/75 pts rec’d >95%            Confounding factors related
of the Intergroup 0099 (INT 0099) regimen                                             Compared by compliance                 planned RT dose, 43%pts rec’d all cycles of concurrent      to decision re tube insertion
in locally advanced nasopharyngeal cancer                 N=75                        • Grp A – 25 did not deviate from      chemo & 61% pts rec’d all cycles adjuvant chemo             was acknowledged.
                                                                                        INT0099                              Factors such as lower body weight at start of therapy,
with a focus on patients' nutritional status.
                                                          All locally advanced, non   • Grp B – 50 did deviate from          female sex, non-Asian descent, and Stage III disease        No details provided re the
Int J Radiat Oncol Biol Phys 2004;60:1127-                metastatic NPC patients                                            were more common in those who deviate.                      nature of dietetic intervention
                                                                                        INT0099
36.                                                       treated with CRT with the                                                                                                      for these patients.
                                                          INT 0099 regimen.           Compared by tube feeding               Toxicity – Only 1 case of Grade 4 (skin), high incidence
                                                          66 - 70 Gy delivered in     • Grp 1 – 23 prophylactic feeding      of lower grade toxicities (nausea and vomiting,
                                                          33–35 fractions + 3           tube                                 pharyngeal)
                                                          adjuvant cycles chemo       • Grp 2 – 17 feeding tube during
                                                          post CRT.                     treatment                            Weight change –
                                                                                      • Grp 3 – 35 no feeding tube           Grp3 (no tube) had the least drop in weight, (nadir
                                                                                                                             weight of 86.6% of their baseline). By 6months and 1
                                                                                      Outcomes:                              year after therapy- recovered to 88.8% and 92.0% of
                                                                                      • Compliance with INT0099 (<95%        baseline weight.
                                                                                         intended dose or delay >7days)      Grp2 had the highest baseline weight, but had the fastest
                                                                                      • Toxicity – RTOG                      drop to reach their nadir of 84.3% of baseline weight
                                                                                                                             (117days - at 1 year, only to 87.2% of baseline weight.
                                                                                      • Weight change
                                                                                                                             Grp 1 had a much slower drop to their nadir weight (186
                                                                                      • Feeding tube use
                                                                                                                             days) and recovered to the greatest degree by 1 year,
                                                                                                                             93.6% of baseline weight.

                                                                                                                             %Pts with >10% wt loss at nadir (Grp1 = 91%, Grp 2 =
                                                                                                                             88%, Grp 3= 69%)

                                                                                                                             Feeding tube use – 40/75pts Weight loss, stomatitis, and
                                                                                                                             pharyngeal dysfunction were cited as the most common
                                                                                                                             reasons for feeding tube insertion.
                                                                                                                             Feeding tubes appeared to be well tolerated among
                                                                                                                             patients who completed therapy without deviation, but
                                                                                                                             among those who deviated from intended therapy, there
                                                                                                                             was a 21.4% infectious complication rate. (overall 7/40
                                                                                                                             had infectious complications).

                                                                                                                             Mean duration Grp1 144.6d vs. Grp2 116.1d
                                                                                                                             Pts who successfully completed planned treatment had a
                                                                                                                             higher baseline wt and were more likely to have
                                                                                                                             prophylactic feeding tube.

Bairati I, Meyer F, Jobin E, et al.             II +      RCT – double blinded,       1.   400IU a-tocopherol + 30mg b-      All cause mortality increased in the supplement arm.        Note – b-carotene ceased
Antioxidant vitamins supplementation and                  multi-centre, Canada             carotene                                                                                      after 156 pts due to concerns
mortality: a randomized trial in head and                                             2.   placebo                           Cause specific mortality tended to be higher in the         with safety following other
                                                          N=540                                                              supplement arm.                                             reported trials.
neck cancer patients. Int J Cancer
                                                                                      Supplements taken for duration of RT
2006;119:2221-2224.                                       Stage I and II H&N SCC      and 3 years post. Follow up
                                                          having RT.                  information every 6 months during 3
                                                                                      years post RT, then annual until end
                                                                                      of study.

                                                                                      Outcomes:
                                                                                      •    Mortality
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes                Results                                                      Comments
                                              Quality
Bairati I, Meyer F, Gelinas M, et al.         II +      RCT – double blinded,       3.   400IU a-tocopherol + 30mg b-      Intervention group tended to less severe adverse effects     Note – b-carotene ceased
Randomized trial of antioxidant vitamins to             multi-centre, Canada             carotene                          (OR = 0.72).                                                 after 156 pts due to concerns
prevent acute adverse effects of radiation                                          4.   placebo                                                                                        with safety following other
                                                        N= 540                                                             Combination of supplements resulted in statistically         reported trials.
therapy in head and neck cancer patients. J
                                                                                    Supplements taken for duration of RT   significant reduction in adverse effects for larynx
Clin Oncol 2005;23:5805-13.                             Stage I and II H&N SCC      and 3 years post. Assessed at          (OR=0.38) and overall at any site (OR=0.38).                 Beneficial effects not seen
                                                        having RT                   baseline, end of RT and 1 month post                                                                when a-tocopherol taken
                                                                                    RT                                     No effect on QOL.                                            alone.

                                                                                    Outcomes:                              May compromise RT efficacy due to increased local
                                                                                    •   Adverse effects of RT              recurrence (Hazard ratio 1.37).
                                                                                    •   QOL
Bairati I, Meyer F, Gelinas M, et al. A       II +      RCT – double blinded,       1.  400IU a-tocopherol + 30mg b-       Intervention group had a higher rate of recurrence or        Note – b-carotene ceased
randomized trial of antioxidant vitamins to             multi-centre, Canada            carotene                           second primary cancers during supplementation period         after 156 pts due to concerns
prevent second primary cancers in head and                                          2.  placebo                            (HR = 1.86), but lower rate after supplementation ceased     with safety following other
                                                        N= 540                                                             (HR = 0.71).                                                 reported trials.
neck cancer patients. J Natl Cancer Inst
                                                                                    Supplements taken for duration of RT
2005;97:481-8.                                          Stage I and II H&N SCC      and 3 years post with median follow-
                                                        having RT                   up of 52 months.

                                                                                    Outcomes:
                                                                                    •    Survival
                                                                                    •    2nd primary ca
                                                                                    •    Recurrence
Bankhead RR, Fisher CA, Rolandelli RH.        III-2 Ø   Comparative cohort study,   Gastrostomy tube inserted as per       Insertion times longer in OPEN vs. LAP and PEG               9/91 H&N pts - It’s not stated
Gastrostomy tube placement outcomes:                    USA                         surgeon preference.                    p<0.05                                                       how many of these 9 patients
comparison of surgical, endoscopic, and                                                                                                                                                 were in each of the LAP,
                                                        N=91                        6 days post op:                        Insertion complications: LAP (3 cases) and PEG (1 case)      PEG and OPEN groups so the
laparoscopic methods. Nutr Clin Pract
                                                                                    Tube insertion times and                                                                            applicability of the outcomes
2005;20:607-12.                                         Patients undergoing         complications, tube maintenance,       Tube maintenance complications higher in the LAP             to the head and neck
                                                        gastrostomy – compared      enteral feeding complications, cost.   group (3 cases)                                              population can’t be
                                                        PEG, LAP (laparotomy                                                                                                            determined.
                                                        procedure) and OPEN                                                20 enteral feeding complications in 17 patients across all
                                                        surgical procedure.                                                groups (9 LAP, 6 PEG, 5 OPEN)

                                                                                                                           Overall complications lower in PEG and OPEN groups
                                                                                                                           compared to LAP group

                                                                                                                           Feeding start day delayed in OPEN group (2.1 days) vs.
                                                                                                                           PEG (1.7 days) and LAP (1.5 days). P<0.05

Baredes S, Behin D, Deitch E. Percutaneous    IV -      Case series, USA            PEG tube placement – standard pull     Complication rate 10.9% (all in stage III or IV)             Limited methodology and
endoscopic gastrostomy tube feeding in                                              method                                 •    Granulation tissue n=3 (at weeks 3,8,73)                statistical descriptions.
patients with head and neck cancer. Ear,                N=55                                                               •    Tube malfunction n=1 (at week 4)                        Confounders not accounted
                                                                                    Monitored complications                •    Tube migration n=1 (at week 6)                          for.
Nose and Throat Journal 2004;83:417-9.
                                                        Patients with SCC of the                                           •    Tube leakage n=1 (at week 19)
                                                        head and neck who had                                              Timing of placement:
                                                        undergone a PEG                                                    •    At resection n=31
                                                        procedure.                                                         •    Post op n=16
                                                                                                                           •    Pre-op n=1
                                                                                                                           •    Non surgical pts n=7
                                                                                                                           Mean LOS = 18 days (+ 16)
Citation                                        Level &   Study Design & Sample        Intervention & Outcomes               Results                                                      Comments
                                                Quality
Barringer DA, Hutcheson KA, Sturgis EM,         IV Ø      Case series, USA             Outcomes:                             OPSE scores NSD after induction chemotherapy;                Very small numbers but deals
Kies MS, Lewin JS. Effect of induction                                                 Functional analysis of speech and     however, patient-reported swallowing and diet levels         with a well-defined group
chemotherapy on speech and swallowing                     N=15                         swallow (OPSE)                        were significantly higher (p < .001 and p < .015,            (young pts with oral cancers).
                                                                                                                             respectively). Diet levels improved from soft chewable
function in patients with oral tongue cancer.
                                                          Phase II clinical trial of   Time points:                          to full diet in most patients. Speech intelligibility NSD.   Only really of interest if we
Head Neck 2009;31:611-7.                                  induction chemotherapy       Pre and post induction chemo                                                                       are looking at changes in
                                                          followed by surgical                                               Mean composite scores from MDADI (emotional,                 practice i.e. a move to
                                                          resection for oral cavity                                          physical, and functional subscales) increased                induction chemo.
                                                          cancer.                                                            significantly, from 74.0 to 87.3, after induction
                                                                                                                             chemotherapy (p < .001).
Beaver ME, Myers JN, Griffenberg L,             IV Ø      Retrospective Case series,   Percutaneous fluoroscopic             Successful tube placement rate 98%                           No prophylactic use of
Waugh K. Percutaneous fluoroscopic                        USA                          gastrostomy tube placement            Complications 1% major (misplacement of the tube), 4%        antibiotics.
gastrostomy tube placement in patients with                                                                                  minor ( site infection and site bleeding,)
                                                          N=92                         Outcomes:                                                                                          Poor definition of
head and neck cancer. Arch Otolaryngol
                                                                                       Immediate, delayed & long term        Tube malfunctions                                            complication terms.
Head Neck Surg 1998;124:1141-4.                           Head and neck cancer         complications of tube placement;      •    Migration into duodenum 9%
                                                          patients requiring PEG       tube malfunction rate; and tube       •    Tube dislodgement 13%                                   Extensive reporting of all
                                                          insertion.                   placement failure.                    •    Delayed leakage at insertion site 4%                    complications and problems,
                                                                                                                             •    Inadvertent tube removal by patient 2%                  however this is retrospective
                                                                                                                                                                                          audit.
                                                                                                                             Most common tumor sites of pts requiring PEG =
                                                                                                                             oropharynx (40%), oral cavity (27%).

                                                                                                                             Site infection rate without antibiotics=2% compared
                                                                                                                             with endoscopic method = 9-20%.
Beaver ME, Matheny KE, Roberts DB,              IV Ø      Retrospective chart          Enteral feeding (n/g or PEG) vs. no   Severe wt loss during XRT=32.7% (i.e. >.5% in 1/12),         Selection bias: No definition
Myers JN. Predictors of weight loss during                review, case series          enteral feeding.                      not affected by T stage, dose of RT or fractionation         of decision making in relation
radiation therapy. Otolaryngol Head Neck                                                                                     schedule.                                                    to whether N/G or PEG used:
                                                          N=249, SCC nasopharynx,                                                                                                         depends on head and neck
Surg 2001;125:645-8.
                                                          oral cavity/oropharynx,                                            32% required feeding tubes at some time during Rx:           surgeon.
                                                          hypopharynx, supraglottic                                          16%during, 12% prior and 4% after. Patients with T3-4
                                                          larynx undergoing                                                  had more tubes placed than smaller tumors.                   Clearly defined inclusion and
                                                          definitive or post op XRT.                                                                                                      exclusion criteria.
                                                                                                                             11% of the group required admission to hospital for
                                                          Excluded incomplete                                                dehydration, significantly higher for nasopharynx and        Reports prophylactic peg
                                                          records, incomplete Rx,                                            CRT. Pts with severe pre-Rx wt loss had high                 placement of 32% (which
                                                          palliative/ short term Rx.                                         admissions for dehydration despite more PEG’s.               would be 80), but this was
                                                                                                                                                                                          total number placed overall
                                                                                                                             Nasopharynx Ca pts significantly more severe wt loss         (which was 105 according to
                                                                                                                             compared with the other sites (oral cavity / oropharynx,     Table 3).
                                                                                                                             hypopharynx, larynx) p<0.05.
                                                                                                                             For oral and oropharynx: Ca: BOT significantly more          Not clear what significance
                                                                                                                             wt loss than tongue/tonsil/RMT/buccal (p<0.05).              levels relate to within tables
                                                                                                                                                                                          of results.
                                                                                                                             Significantly less severe wt loss during Rx in those who
                                                                                                                             had pre-treatment tubes vs. no tube or tube placed during    Poorly written and difficult to
                                                                                                                             Rx (p<0.05).                                                 link the discussion and the
                                                                                                                                                                                          tables.
                                                                                                                             Patients who had lost>7% of BMI before RT had
                                                                                                                             significantly higher incidence of severe wt loss.

                                                                                                                             Those who had surgery and post-op RT had a lower
                                                                                                                             incidence of severe wt loss.
Citation                                         Level &   Study Design & Sample        Intervention & Outcomes                   Results                                                        Comments
                                                 Quality
Beer KT, Krause KB, Zuercher T, Stanga Z.        III-2 Ø   Retrospective Cohort         1.   Early PEG: before or within 2        Early PEG vs. late PEG                                         Malnutrition not defined.
Early percutaneous endoscopic gastrostomy                  study, Switzerland                wk RT,                               •    Less wt loss ( 1.03kg vs. 3.58kg) p=0.004
insertion maintains nutritional state in                                                2.   Delayed PEG after 2/52 RT up         •    Decreased malnutrition rate at the end of Rx (31%         Significantly higher smoking
                                                           N=151                             to 3/12                                   vs. 60%) p=0.002                                          and Ethanol intake in early
patients with aerodigestive tract cancer. Nutr
                                                                                                                                  •    Fewer RT interruptions (10% vs. 25%) p=0.01               PEG group.
Cancer 2005;52:29-34.                                      Patients with upper          FREKA®: Pull PEG 95%, push PEG
                                                           aerodigestive tract cancer   5%. Patients were enterally fed and       PEG complications
                                                           undergoing RT( 61%)/         allowed oral clear fluids if tolerated.   •   8.6% wound infection,
                                                           chemoRT (39%) and                                                      •   3.3% tube dislodgement,
                                                           planned for PEG on the       Outcomes:                                 •   1.3% tube obstruction.
                                                           basis of unable to meet      Mucositis, wt loss, diff in BMI,          Major complications
                                                           basis energy needs by oral   malnutrition prevalence.                  •   1.3%: fistula & stoma leakage in the peritoneum
                                                           intake.
                                                                                        Measured at end of RT. follow-up to
                                                                                        340 or 208 days.
Bertrand PC, Piquet M-A, Bordier I,              IV -      Observational,               Pre-op diet intervention average          53% malnourished at baseline.                                  Limited study – part
Monnier P, Roulet M. Preoperative                          Switzerland                  13days:                                                                                                  observational and part
nutritional support at home in head and neck                                            Well nourished (n=127) – general          Alcohol abusers (>60g/d) more frequently moderately            literature review.
                                                           N=270                        dietary counselling                       malnourished (p<0.01) or severely malnourished
cancer patients: from nutritional benefits to
                                                                                        Moderately malnourished (n=104) –         (p<0.04) than alcohol consumers.                               Outcome of wt change
the prevention of the alcohol withdrawal                   HNC pts                      oral nutrition supplements                                                                               unclear if average of all
syndrome. Curr Opin Clin Nutr Metab Care                                                Severely malnourished (n=39) – tube       Mean wt increase of 1.3kg.                                     groups.
2002;5:435-40.                                                                          fed (33% PEG, 67% NGT). PEG
                                                                                        chosen for those having surgery + RT
Bleier BS, Levine MS, Mick R, et al.             IV Ø      Case series, USA             Intervention: effect of treatment on      •   Mean tube dependence post RT/CRT 18mth (0-                 Provides details of the nature
Dysphagia after chemoradiation: analysis by                                             swallow                                       115mth)                                                    of long term problems but
modified barium swallow. Ann Otol Rhinol                   N=49                                                                   •   No relationship between tumour site or pneumonia           can’t determine overall
                                                                                        Outcomes:                                     on need for tube                                           incidence because only
Laryngol 2007;116:837-41.
                                                           Stage I-IV SCC H&N           • Swallow function                        •   79.6% needed a feeding tube in follow-up period            examining those pts
                                                           RT or CRT with post          • Tube dependence                         •   31.9% pts had pneumonia in follow-up period                presenting for MBS (and
                                                           treatment dysphagia.         • Pneumonia                               •   40.5% pts were tube dependent at 12mths post               timing of MBS was 0-84mths
                                                                                                                                      treatment                                                  post treatment! – appears
                                                                                                                                                                                                 only 1 x MBS per pt??)
                                                                                                                                                                                                 Title says CRT and yet 26.5%
                                                                                                                                                                                                 did not receive chemo.
Brookes GB. Nutritional status--a prognostic     IV Ø      Cohort, UK                   Assessment of baseline nutritional        Baseline nutritional status 38% under nutrition.
indicator in head and neck cancer.                                                      status using “General Nutrition
Otolaryngol Head Neck Surg 1985;93:69-                     N=114                        Score” (wt change, MAMC, TSF,             N=78 had f/up survival data.
                                                                                        albumin, transferrin, N balance)
74.
                                                           Scc H&N                      Outcome:                                  Well nourished had improved 2 year survival (57.5%
                                                                                        • Survival                                compared to 7.5%) P=0.0
Bruning PF, Halling A, Hilgers FJ, et al.        III-2 Ø   Case series, Netherlands     First 8 patients were fed via a PEG       A diminished muscle protein breakdown, even in the
Postoperative nasogastric tube feeding in                                               feeding tube at 50% greater than their    presence of an ample nutritional supp~ of energy and
patients with head and neck cancer: a                      N=20                         estimated requirements (group A);         protein. A transient decrease of serum albumin, iron and
                                                                                        the following 12 patients were fed at     zinc in all patients is likely not to be related to
prospective assessment of nutritional status
                                                           Postoperative Nasogastric    100% greater than their estimated         nutritional intake, but to surgery itself. Analysis of trace
and well-being. Eur J Cancer Clin Oncol                    Tube Feeding in Patients     requirements (group B).                   minerals and vitamins in blood and amino acids in serum
1988;24:181-8.                                             with Head and Neck           Outcomes:                                 and urine showed no deficiencies or amino acid
                                                           Cancer                       Weight, lean body mass, body fat          imbalance. Assessment of the psychosocial impact of the
                                                                                        mass, serum and urine pathology test,     nasogastric tube feeding regimen revealed gastro-
                                                                                        tolerance to TF.                          intestinal complaints in a minority, and feelings of being
                                                                                        Time points:                              deprived of the act of eating and drinking in the majority
                                                                                        Day before surgery (t0), on day 7         of patients.
                                                                                        (t1), day 21 (t3).
Citation                                       Level &   Study Design & Sample     Intervention & Outcomes                  Results                                                     Comments
                                               Quality
Buijs N, Schueren MAd, Langius JA, et al.      II Ø      RCT (double blind)        Intervention:                            Arginine Group vs. Control Group:                               Authors state only
Perioperative arginine-supplemented                      Netherlands               Both groups received EN                  Median overall long-term survival: 34.8mo vs. 20.7mo            difference between
nutrition in malnourished patients with head                                       preoperatively for 7-10d via NGT;        (p=0.019).                                                      standard and arginine
                                                         N=32 (severely            and from Day 1 postoperatively to        Disease-specific survival 94.4mo vs. 20.8mo (p=0.022).          formula is the arginine
and neck cancer improves long-term
                                                         malnourished pts with     10d after surgery. If pts in the                                                                         content but note
survival. Am J Clin Nutr 2010;92:1151-6.                 HNSCC; malnutrition       intervention group needed tube           Differences for survival remained significant after Cox         glutamine is higher in
                                                         defined as >10% wt loss   feeding > 10d, they were changed to      regression analysis performed to test for confounding           standard formula.
                                                         in 6/12 prior)            standard formula.                        and effect modification (N stage, wt loss and T stage)          Target intake based on
                                                                                                                            (p=0.031).                                                      1.5 x BEE based on
                                                                                   Control Group (n=15)                                                                                     ABW.
                                                                                   Standard preoperative and                Arginine supplementation had a positive influence on            Authors comment the
                                                                                   postoperative EN.                        both:                                                           study is innovative
                                                                                                                            -     overall survival: (HR: 2.632; 95% CI: 1.142,              because it involved single
                                                                                   Intervention Group (n=17 )                     6.061)                                                    nutrient supplementation,
                                                                                   Arginine-supplemented preoperative       -     disease-free survival: (HR: 4.167; 95%CI: 1.389,          homogeneous patient
                                                                                   and postoperative EN.                          12.500)                                                   groups and the length of
                                                                                                                                                                                            follow-up.
                                                                                   No significant differences in baseline   Absence of extracapsualr spread had a positive effect on
                                                                                   characteristics.                         disease-free survival (HR: 2.8120; 95%CI 1.008, 7.831)      To the authors’ knowledge,
                                                                                                                            but not overall survival.                                   this is the first study to show
                                                                                   Outcomes:                                                                                            nutrition intervention with
                                                                                   Primary:                                 Median time to locoregional recurrence could not be         arginine-enriched nutrition
                                                                                   Long-term (>10y survival)                estimated in the arginine group but was >92.8mo and         before and after surgery may
                                                                                                                            was estimated at 10.6mo in the control group (P=0.027).     improve survival.
                                                                                   Secondary:
                                                                                   Long-term appearance of                  Locoregional recurrence-specific survival differed
                                                                                   locoregional recurrence, distant         significantly between the 2 groups (P=0.010) with the
                                                                                   metastases, second primary tumours.      observed effect even more profound when confounders
                                                                                                                            accounted for.

                                                                                                                            Conclusion:
                                                                                                                            Study results should be considered promising; still
                                                                                                                            numbers are small and study was not adequately
                                                                                                                            powered or designed to rule out confounding factors
                                                                                                                            such as lifestyle, exercise, alcohol intake etc. However,
                                                                                                                            the study suggests arginine-enriched nutrition given
                                                                                                                            perioperatively may be a valuable tool for improving
                                                                                                                            long-term survival in malnourished HNC pts. Larger
                                                                                                                            studies are required to confirm these results.
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes            Results                                                      Comments
                                               Quality
Buiret G, Combe C, Favrel V, et al. A          IV Ø      Case series, multicenter     Intervention (independent          Completion rates:                                            Retrospective study, not in
Retrospective, Multicenter Study of the                  France                       variables):                             -     ICT-73.9% (34)                                    context of clinical trial.
Tolerance of Induction Chemotherapy With                                              Induction chemo followed by             -     ERT-93.5% (43)
                                                         N=46                         RT/cetuximab                            -     Cetuximab-69.6% (32)                              All patients stage III/IV.
Docetaxel, Cisplatin, and 5-Fluorouracil
                                                                                                                         Weight loss (mean):                                          Small % had double
Followed by Radiotherapy With                            Stage III-IV SCC oral        Outcomes:                               -     During ICT: 157g/wk (p=0.456)                     localization. Some patients
Concomitant Cetuximab in 46 Cases of                     cavity, oropharynx,             Proportion of patients who           -     During RT/cetux phase: 252g/wk (p=0.0145)         had surgery after ICT (?
Squamous Cell Carcinoma of the Head and                  hypopharynx, larynx, neck       completed protocol                   -     During entire treatment period:                   impact on RT toxicities).
Neck. International Journal of Radiation                 met with unknown                Safety of treatment (adverse                  -4.8% of BW
Oncology Biology Physics 2010:77 (2) (pp                 primary, lip receiving          events)                                       -21.7% of pts los >10% BW
430-7), 2010.                                            induction chemo                                                 Safety of ICT:
                                                         (doc/cis/5FU) followed by                                            -     Neutropenia (gd 2,3,4): 3 (6.5%) after cycle 1
                                                         RT with concomitant                                                  -     Diarrhoea (gd 2,3): 12 (26.1%) after cycle 1;
                                                         cetuximab.                                                                 3 (7.3%) after cycle 2; 2 (5.8%) after cycle 3;
                                                                                                                                    2 (13.3%) after cycle 4
                                                                                                                              -     Unscheduled hospitalization: 6 (13.1%) after
                                                                                                                                    cycle 1; 5 (15.2%) after cycle 2; 2 (5.8%)
                                                                                                                                    after cycle 3
                                                                                                                              -     Discontinuation: 5 (11%) after cycle 1; 7
                                                                                                                                    (15%) after cycle 2; 19 (41%) after cycle 3;
                                                                                                                                    15 (33%) after cycle 4
                                                                                                                         Safety of ERT with concomitant Cetuximab:
                                                                                                                              -     No grade 4/5 events
                                                                                                                              -     Mucositis: 60% grade 3 at 7th cycle of
                                                                                                                                    cetuximab
                                                                                                                              -     Cetux discontinuation: 14 (30.4%) before
                                                                                                                                    planned no. cycles (causes eg gd 3 mucositis,
                                                                                                                                    rash)
                                                                                                                              -     ERT discontinuation: 18 (39.1%) temporary
                                                                                                                                    discontinuation (dermatisis/mucositis)
                                                                                                                              -     Hospitalisation: 12 (26.1%) for nutritional
                                                                                                                                    support (10 enteral, 2 parenteral)
                                                                                                                              -     5 patients required initiation of nutrition w/o
                                                                                                                                    hospitalization (4 enteral, 1 parenteral)
Büntzel J, Reisenbeck D,Glatzel M et al.       II Ø      Phase II RCT                 Intervention:                      Group A vs. Group B:                                         Selenium substitution may
Limited effects of selenium substitution in              Germany (multicentre)        Group A (n=22)                     Dysphagia           22.7% vs. 35.3%                          reduce typical radiation-
the prevention of radiation-associated                                                500μg sodium selenite on RT days   Loss of Taste       22.7% vs. 47.1% (p=0.172)                induced toxicities in HNC
                                                         N=39 (8F, 31M)               and                                Dry mouth           22.7% vs. 23.5%                          with limited effects.
toxicities. results of a randomized study in
                                                         Group A (n=22)               300μg sodium selenite on non-RT    Stomatitis          36.4% vs. 23.5%                          Combinations with other
head and neck cancer patients. Anticancer                Group B (n=17)                                                                                                               scavengers such as amifostine
                                                                                      days.
Res 2010;30:1829-32.                                     No significant diff                                             Overall, no statistically significant differences in mean    should be investigated in
                                                         between groups at            Group B (n=17)                     values between groups. Dysphagia was statistically           future studies.
                                                         baseline.                    Control – RT alone, nil selenium   significant at Wk 7 (p=0.05).
                                                         Individuals with decreased   supplementation.
                                                         endogenous serum-                                               Conclusion:
                                                         concentrations of Se,                                           Small RCT showed limited effects of selenium in the
                                                         advanced SCC HNC,                                               prevention of ageusia and dysphagia due to RT of HNC.
                                                         undergoing definitive or
                                                         adjuvant RT (where Rx
                                                         field included >75% of
                                                         major salivary glands),
                                                         oral cavity, oropharynx,
                                                         hypopharynx, unknown
                                                         1°.
Citation                                       Level &   Study Design & Sample         Intervention & Outcomes                 Results                                                    Comments
                                               Quality
Califano L, Zupi A, Giardino C. Enteral        III-2 -   Cohort, Italy                 Group A -Patients who suffered from     All parameters showed a reduction over time from pre       Not clinically relevant paper.
nutrition in maxillo-facial surgery. Rev                                               head and neck tumours (n=12)            nutrition support to post. With more change observed
Stomatol Chir Maxillofac 1992;93:388-92.                 N=24                          Group B - Traumatic lesions in the      and lower values in group A compared to group B.           Poor methodology details.
                                                                                       maxillo-facial area (n=12)
                                                         Patients who were                                                     Weight:
                                                         subjected to enteral          Intervention: NG feeds 12-20 days       Mean wt loss 1.5-2kg.
                                                         alimentation in the Dept of
                                                         Maxillofacial Surgery.        Outcomes:
                                                                                       Weight, Anthropometry, Serum
                                                                                       proteins, Immune markers
Campbell IT, Morton RP, Macdonald IA,          II Ø      RCT, UK                       Patients randomised to overnight        Oxygen consumption (VO2) increased in both groups          Feeding at night only is more
Judd S, Shapiro L, Stell PM. Comparison of                                             continuous feeding (1700 – 0900)        after feeding started. The increase was higher in the      energy efficient but
the metabolic effects of continuous                      N=18                          (n=9) or 24 hour continuous feeding     night-fed group p=0.0109                                   associated with poorer
                                                                                       (n=9).                                                                                             nitrogen balance.
postoperative enteral feeding and feeding at
                                                         Patients who underwent                                                Nitrogen balance achieved in the 24hr fed group but not
night only. Am J Clin Nutr 1990;52:1107-                 major surgery for             On day 1 after surgery, patients were   the night fed group p<0.05
12.                                                      malignant disease of the      given a total of 4.7MJ. On days 2-5,
                                                         buccopharynx and larynx.      patients were given 10MJ/day.           Serum glucose and insulin both increased post op.
                                                                                       Outcomes:                               p<0.01
                                                                                        • Oxygen Consumption                   Glucose higher in night fed.
                                                                                        • Urinary Nitrogen                     Insulin higher in night fed NS.
Campos AC, Butters M, Megwid MM.               IV Ø      Case series, USA              Surgical Gastrostomy Tube (SGT)         n=10 patients with end stage disease – all died of their   Technique of surgical method
Home enteral nutrition via gastrostomy in                                              insertion                               disease 2-95 days post tube placement and excluded         of G-tube placement not
advanced head and neck cancer patients.                  N=39                                N=19, Dysphagia, Anorexia,        from further analysis.                                     frequently used.
                                                                                             NBM, Malnutrition
Head Neck 1990;12:137-42.
                                                         Patients with advanced              N=10, Fistulae following RT       SG complications:                                          Poor definition of
                                                         (n=29) or end stage                 and Surgery                       Overall rate = 23% - Cellulitis (n=1), blocked tube        complications and end stage.
                                                         disease (n=10) for                                                    (n=3), pulled out (n=4), tube migration – causing
                                                         palliative care who had a     Patient / family trained on bolus EN    obstruction (n=1)
                                                         gastrostomy tube inserted     by a nutritional team nurse over 5-7d

                                                         Tumour site:                  Outcomes:
                                                             N=26,Head& Neck           •   Complications
                                                             N=2,Oesophagus
                                                             N=1, Lung
Cantwell CP, Perumpillichira JJ, Maher         III-3 Ø   USA                           N=20 – no antibiotics given             0% 30day mortality                                         Good definition of
MM, et al. Antibiotic prophylaxis for                                                                                          0% major complication rate                                 complications.
percutaneous radiologic gastrostomy and                  N=57                          N=37 - Antibiotic prophylaxis (1g       14% minor complication rate
                                                                                       cefazolin IV or 600mg clindamycin                                                                  Confounders not accounted
gastrojejunostomy insertion in outpatients
                                                         Patients who had head and     IV in penicillin allergic patients).    Fewer infections and post procedure pain in the group      for.
with head and neck cancer. J Vasc Interv                 neck cancer who                                                       who received antibiotic prophylaxis. P=0.039
Radiol 2008;19:571-5.                                    underwent percutaneous        Patients were followed up 24hours
                                                         radiologic gastrostomy        post procedure, and 7 – 10 days post    Tube dislodgement n=4 mean of 13.3 weeks (3 – 32).
                                                         (PRG, n=53) or                procedure. Mean follow up was 27
                                                         gastrojejunostomy (GJ,        weeks (4 – 62 weeks).                   Post procedural pain was controlled by self administered
                                                         n=4) placement as                                                     analgesia (n=40/41 available data).
                                                         outpatients.                  Outcomes:
                                                                                       Complications, post procedural pain     T-fasteners removed mean of 13 d (6 – 22) post
                                                                                       control at 24 hours, duration to T-     procedure.
                                                                                       fastener removal, interval to removal   Tube outcomes:
                                                                                       of the tube.                            •     Removed n=23 (at mean 13.5 weeks)
                                                                                                                               •     In situ n= 25
                                                                                                                               •     Died n= 4
                                                                                                                               •     Lost to follow up n=5
Citation                                    Level &   Study Design & Sample     Intervention & Outcomes                   Results                                                    Comments
                                            Quality
Capuano G, Grosso A, Gentile PC, et al.     IV Ø      Case series, Italy        Nutritional program:                      > 20% loss of pre diagnosis weight correlated with;        Authors acknowledge that
Influence of weight loss on outcomes in                                         1. Intensive dietary counseling,               Treatment interruption (p = .003),                    RCT is needed to compare ±
patients with head and neck cancer                    N=40                          from the start of treatment to the         Infections (p = .002),                                tube feeding however did not
                                                                                    second week of CCRT.                       Early mortality (p = .011),                           discuss other confounders
undergoing concomitant chemoradiotherapy.
                                                      Locally advanced,         2. Enteral nutrition by a                      Hospital readmission rate (r= 0.590, p = .001)        likely when comparing
Head Neck 2008;30:503-8.                              unresectable and non          nasogastric tube (NG), from the            Survival (log-rank test: z = - 2.722, p = .006).      compliant/noncompliant, nor
                                                      metastatic HNC referred       third week of CCRT.                                                                              did they suggest
                                                      for CCRT.                 3. Intensive dietary counseling,          47% pts (19) were non-compliant i.e. “did not accept the   reasons/strategies for
                                                                                    from NG removal to the                nutritional counselling” “... refused NG or PEG and        noncompliance.
                                                                                    resumption of normal food             continued oral during CCRT”.
                                                                                    intake.                               90% of C pts maintained body weight and 100% of non        Data collected over 4yrs (? no
                                                                                                                          C pts continued to lose weight.                            changes in protocol) and their
                                                                                Outcomes:                                                                                            protocol had a high 30day
                                                                                Wt and % wt loss                          Dx to end CCRT                                             mortality (18%) and yet
                                                                                                                          Wt change (mean, SD), % wt change (median, range);         almost no long-term
                                                                                Time points:                              C pts, 1 ± 2.3 kg (p=0.084), 0% (0-7)                      dysphagia!!??
                                                                                Baseline, at the end, and 30 days after   non C pts, -9 ± 4 kg; (p < .001), 11% (3-22)
                                                                                CCRT.                                     Dx to 30 days post CCRT
                                                                                                                          <20% wt l loss = 95% C pts vs. 16% non C pts
                                                                                Compared outcomes in compliant (C         >20% wt l loss = 5% C pts vs. 84%pts non C pts
                                                                                pts) and non-compliant pts (non C         Serum prealbumin (mean); C pts 30 ± 5 mg/dL vs. non
                                                                                pts).                                     C pts 15 ±4mg/dL (p< .001)

                                                                                                                          Type of nutrition support
                                                                                                                          C pts: the median EN duration was 30 days (range, 10–
                                                                                                                          93), and ONS resumed frequently the day after CCRT
                                                                                                                          completion (median, 0; range, 0–58 days). (early!!). Nil
                                                                                                                          pts required PN.

                                                                                                                          Non C pts: 17 of the 19 noncompliant pts (89%) stopped
                                                                                                                          oral intake by week 3-4, 16 were admitted with severe
                                                                                                                          dehydration & malnutrition (1 died before admission) &
                                                                                                                          rec’d PN (NGT insertion “impossible”) - ?2 continued
                                                                                                                          ONS?

                                                                                                                          Complications
                                                                                                                          •   No different compliant vs. noncompliant.
                                                                                                                          •   NGT dislodged & replaced in 6 pts (30%).
                                                                                                                          •   PN more expensive than EN median Euros 50 vs.
                                                                                                                              16/day (clearly not including cost of admission!).
                                                                                                                          •   Persistent late dysphagia (not defined) – C pts = 0,
                                                                                                                              non C pts = 1 (required long term PEG).
                                                                                                                          •   No association between compliance and tumour
                                                                                                                              site or field size.
                                                                                                                          •   All pts severe mucositis & dysphagia (grade3-4)
                                                                                                                              by wk 3.
Citation                                       Level &     Study Design & Sample      Intervention & Outcomes               Results                                                     Comments
                                               Quality
Capuano G, Gentile PC, Bianciardi F, Tosti     IV +        Cohort, Italy              Prevalence of malnutrition and the    36% were malnourished before treatment.
M, Palladino A, Di Palma M. Prevalence                                                possible influence of nutritional
and influence of malnutrition on quality of    Prognosis   N=61                       status on QoL and PS before           Patients who are malnourished vs. well nourished at
                                                                                      treatment.                            baseline are more likely to have:
life and performance status in patients with
                                                           Locally advanced head                                            •     Reduced nutritional intake: 67% vs. 10%
locally advanced head and neck cancer                      and neck cancer patients   Well nourished n=36                   •     Reduced nutritional risk: mean PGSGA score was
before treatment. Support Care Cancer                                                 Malnourished (UWL >5% in 3/12)              3+/-2 vs. 9+/-5
2010;18:433-7.                                                                        n=25                                  •     Higher mean CRP 20.3 +/-22.5 vs. 4.3 +/- 5
                                                                                                                                  (p=0.004)
                                                                                                                            •     Lower pre-Alb (p<0.001)
                                                                                                                            •     Lower Haemoglobin (p<0.001)
                                                                                                                            •     ECOG PS score higher (p=0.018)
                                                                                                                            •     Reduced QoL: in domains of Physical (p=0.043),
                                                                                                                                  role (p=0.047), and social functions (p=0.024)
                                                                                                                                  Fatigue (p<0.001), appetite loss (p<0.001), and
                                                                                                                                  nausea and vomiting (p=0.002)
Casas-Rodera P, Gomez-Candela C, Benitez       II Ø        RCT, Spain                 Post op EN                            Immune markers – no difference                              Small numbers
S, et al. Immunoenhanced enteral nutrition                                            1.    arg EN                                                                                      Underpowered
formulas in head and neck cancer surgery: a                N=44                       2.    std EN                          Infections - STD had increased wound complications
                                                                                      3.    arg, RNA, n-3 FA EN             and general infections (NS)
prospective, randomized clinical trial. Nutr
                                                           Surgery for oral and
Hosp 2008;23:105-10.                                       laryngeal cancers          Outcomes (baseline, 7d and 14d post   LOS – No difference
                                                                                      op)
                                                                                      •    Immune markers
                                                                                      •    Post op infection
                                                                                      •    LOS

Caudell JJ, Schaner PE, Desmond RA,            III-3 Ø     Retrospective cohort       Intervention: IMRT                    Incidence                                                   Doses to the larynx and
Meredith RF, Spencer SA, Bonner JA.                        study, USA                                                       18 of 83 (21.7%) patients PEG dependant at 1 year.          pharyngeal constrictors were
Dosimetric factors associated with long-       Prognosis                              Outcomes:                             22 of 83 (26.5%) patients aspirating.                       strongly associated with
                                                           N=83                       PEG tube dependence at 1 year,        17 of 83 (20.5%) patients had pharyngo-oesophegeal          swallowing outcomes even
term dysphagia after definitive radiotherapy
                                                                                      aspiration and pharyngo-oesophageal   stricture requiring dilation. Median time to diagnosis of   when controlled for clinical
for squamous cell carcinoma of the head and                SCC of the head and neck   stricture.                            stricture was 7 months (3 – 24 months).                     factors.
neck. International Journal of Radiation                   treated with definitive                                          PEG tube dependence at 1 year was associated with
Oncology, Biology, Physics 2010;76:403-9.                  intensity modulated                                              aspiration (p<0.001) and stricture (p=0.008).
                                                           radiotherapy (IMRT).                                             Aspiration was also associated with development of
                                                                                                                            stricture (p=0.002).
                                                                                                                            Stricture > grade 3 associated with primary site
                                                                                                                            (p=0.01).
                                                                                                                            PEG tube dependence at 1 year associated with primary
                                                                                                                            site (p=0.003), T stage (p= 0.004), baseline dysphagia
                                                                                                                            (p<0.001).
                                                                                                                            Aspiration associated with primary site (p=0.001), T
                                                                                                                            stage (0.004).

                                                                                                                            PEG tube dependence – logistic regression analysis
                                                                                                                            Abnormal pre-treatment swallowing status (0.004) &
                                                                                                                            primary site associated (p=0.04) with PEG dependence
                                                                                                                            at 1 year.
                                                                                                                            When controlled for these factors and odds ratio of 1.11
                                                                                                                            (CI 1.04 – 1.19) for the larynx and 1.08 (CI 1.02 – 1.15)
                                                                                                                            for the inferior pharyngeal constrictor is the estimated
                                                                                                                            odds of PEG tube dependence at 1 year for every 1 Gy
                                                                                                                            increase in mean dose.
Citation                                 Level &   Study Design & Sample         Intervention & Outcomes                  Results                                                      Comments
                                         Quality
                                                                                                                          Aspiration – logistic regression analysis
                                                                                                                          Primary site (p=0.01) and higher T stage (p=0.03)
                                                                                                                          associated with aspiration.
                                                                                                                          When controlled for these factors, mean dose to the
                                                                                                                          larynx was significant (OR, 1.07; CI 1.01 – 1.19;
                                                                                                                          p=0.002).

                                                                                                                          Pharyngo-oesophageal stricture – logistic regression
                                                                                                                          analysis
                                                                                                                          Requirement for pharyngo-oesophageal dilation was
                                                                                                                          associated with primary site (p=0.002) and non smokers
                                                                                                                          or ex smokers (p=0.01).
                                                                                                                          When these factors controlled for, superior pharyngeal
                                                                                                                          constrictor V65 with a threshold of 32.7% (p=0.027) and
                                                                                                                          middle pharyngeal constrictor V65 and V70 with
                                                                                                                          thresholds of 74.8% (p=0.032) and 53.4% (p=0.004)
                                                                                                                          respectively were associated with need for a dilation
                                                                                                                          procedure.



Chan CWH, Chang AM, Molassiotis A, Lee   IV -      Case series, Hong Kong        Outcomes:                                The majority of subjects experienced a mild to moderate      Stated that data on nutritional
IYM, Lee GCT. Oral complications in                                              •    Oral status                         degree of mucositis with the highest score reported on       state was collected (BMI) but
Chinese cancer patients undergoing                 N=94                          •    Mucositis-related symptoms          day 8 ( prevalence 12.8% on day 1,                           didn’t provide any data other
                                                                                                                          58.5% on day 8, and 42.5% on day 16).                        than to say not associated
chemotherapy. Support Care Cancer
                                                   Undergoing chemotherapy       Data were collected by a research                                                                     with mucositis. Limited data
2003;11:48-55.                                     with curative intent and at                                            Symptoms with highest scores were oral dryness, oral         presented on oral intake –
                                                                                 nurse over a period of 16 days: at the
                                                   risk of having mucositis      start, on day 8, and on day 16 of        discomfort, and difficulty in chewing/eating.                categories not defined.
                                                   by having stomatotoxic        chemotherapy.
                                                   chemotherapy (e.g. 5FU,                                                Pts with HNC had consistently higher scores for              No description of usual
                                                   ARA-C, Adriamycin, and                                                 mucositis and symptoms in most phases.                       advice re symptom
                                                   VP-16).                                                                                                                             management, oral intake etc
                                                                                                                          Oral mucositis and symptoms were significantly and           despite interest ++ in mouth
                                                   Only 20% pts = H&N                                                     positively correlated with consumption of spicy and/or       cares. Also discussed info
                                                   cancer.                                                                hot (temperature) food, and frequency of use of              that wasn’t presented e.g.
                                                                                                                          mouthwashes.                                                 nature of taste alterations.

                                                                                                                          ??? Higher scores in patients who: ate hot (temperature)     Might be useful as part of
                                                                                                                          food, had low tolerance for hot food and spicy foods,        CAM/health beliefs
                                                                                                                          and were taking Chinese medicinal herbs.                     considerations.

                                                                                                                          The WHO scale and the severity-of-mucositis scale were
                                                                                                                          significantly correlated in all three assessments (r=0.99–
                                                                                                                          1.00, P<0.01).
                                                                                                                          OSA correlated with the total mucositis score at all
                                                                                                                          stages of data collection (r=0.45–0.71, P<0.01).

                                                                                                                          Age, level of education, stage of disease, and BMI,
                                                                                                                          were all unrelated to the degree and symptoms of
                                                                                                                          mucositis.
Citation                                   Level &   Study Design & Sample         Intervention & Outcomes                   Results                                                   Comments
                                           Quality
Chandu A, Smith ACH, Douglas M.            IV Ø      Case series, Australia        Weight was recorded before surgery,       Mean wt loss of 2.2kg (2.9%) from pre op to 2 wk post     Extra 1 year data on top of
Percutaneous endoscopic gastrostomy in                                             2 weeks post surgery and then 4 to 8      op P<0.0022.                                              the paper by smith 2000.
patients undergoing resection for oral               N=49                          weeks post surgery.
                                                                                                                             Mean wt loss of 3.2kg (4.7%) from pre op to 4-8 wks
tumors: a retrospective review of
                                                     All patients undergoing       Outcomes:                                 post op.
complications and outcomes. J Oral                   resection for oral tumors     • Weight/BMI
Maxillofac Surg 2003;61:1279-84.                     and having a PEG 1992-        • Duration PEG use                        Weight change between 2 wks post op and 4-8 wks post
                                                     2001.                         • Timing of PEG placement                 op NS
                                                                                   • PEG complications
                                                                                                                             Difference between pre op and post op BMI
                                                                                                                             measurements. NS

                                                                                                                             Time of placement:
                                                                                                                             N=41 at time of surgery, N=7 pre op, N=2 post op
                                                                                                                             Complications: minor n=5 (10%), major n=4 (8%)
                                                                                                                             Duration of use:
                                                                                                                             N=31, removed (mean use 114 days)
                                                                                                                             N=10 RIP with PEG in-situ
                                                                                                                             N=7, PEG in use due to dysphagia/aspiration (mean use
                                                                                                                             413 days post op)

Chang JH, Gosling T, Larsen J, Powell S,   III-2 Ø   Retrospective cohort          Observational study: prophylactic         Peg group – higher incidence of stage III + IV, CRT and   Variable practice amongst
Scanlon R, Chander S. Prophylactic                   study, New Zealand            PEG (n=7) vs. standard care (n=64).       previous wt loss >10% 6/12                                medical staff.
gastrostomy tubes for patients receiving
                                                     N=71                          No criteria for prophylactic PEG –        PEG group lost 5.2% less wt than the control P=0.016      Threshold for initiating feeds
radical radiotherapy for head and neck
                                                                                   commenced feeding when required.                                                                    thru PEGs was lower than
cancers: a retrospective review. J Med               Pts with primary HNCs                                                                                                             inserting a NGT.
Imaging Radiat Oncol 2009;53:494-9.                  having bilateral neck large   Std care received NG if required          Admission for nutritional reasons NS
                                                     field radical RT of >60 Gy    (44%). Generally indicators for NGT                                                                 Variation in baseline
                                                     + surgery or chemo.           were unable to take adequate                                                                        characteristics controlled for
                                                                                   nutrition orally or lost significant wt                                                             in analysis.
                                                                                   (5%).
                                                                                                                                                                                       Note that contact author is at
                                                                                   Outcomes:                                                                                           Peter MacCallum but the
                                                                                   • Wt loss and % wt loss during                                                                      study was done in NZ.
                                                                                       Rx,
                                                                                   • Admissions for nutrition –
                                                                                       related factors
                                                                                   • Treatment interruptions
Citation                                    Level &   Study Design & Sample        Intervention & Outcomes                   Results                                                      Comments
                                            Quality
Chen AM, Li B-Q, Lau DH, et al.             III-2 Ø   Retrospective chart audit    Intervention:                             No difference in the 3-year estimates of overall survival    16 of the 50 patients (32%)
Evaluating the role of prophylactic                   of 120 consecutive           70 patients (58%) received                among those with and without prophylactic GT                 who did not have
gastrostomy tube placement prior to                   patients treated with        prophylactic GT placement at the          placement (p = 0.54).                                        prophylactic GT placed
                                                      chemoXRT for Stage           discretion of the physician before                                                                     before initiation of radiation
definitive chemoradiotherapy for head and
                                                      III/IV head and neck         initiation of chemoradiotherapy. No       The average net weight loss (from first to last day of       therapy ultimately required
neck cancer. International Journal of                 cancer to a median dose of   Ng tubes were used. Patients with         XRT) for patients treated with vs without prophylactic       emergent GT placement at a
Radiation Oncology, Biology, Physics                  70 Gy (range, 64–74 Gy)      prophylactic GT were encouraged to        GT was 19 pounds (range, 0–51 pounds) and 43 pounds          median of 33 days (range,
2010;78:1026-32.                                      2001-2009 at University      undergo feeding by mouth for as long      (range, 0–76 pounds), respectively, which corresponded       22–43 days) after the start of
                                                      of California. The most      as it was tolerable.                      to a net change of –8% (range, +1% to –22%) and –14%         treatment (p < 0.001).
                                                      common primary site was                                                (range, 0% to –30%) reduction from their baseline
                                                      the oropharynx (66           Decisions to initiate GT feeds were       weight, respectively (p < 0.001, for both absolute and
                                                      patients). Sixty-seven       based on individual patient and           percentage weight loss). No significant difference in wt
                                                      patients (56%) were          chemoXRT-induced toxicities with          loss @3/12 or 6/12.
                                                      treated using intensity-     specific emphasis placed on inability
                                                      modulated radiotherapy       to consume adequate oral nutrition        The proportion of patients requiring intravenous fluid
                                                      (IMRT).                      and fluid, dysphagia, and prevent         hydration was 17% and 54% among those with and
                                                                                   uncontrolled involuntary weight loss      without PEG (p=0.03).
                                                                                   (5%–10% of initial weight).
                                                                                                                             No diff in Rx compliance, unplanned breaks,
                                                                                   Follow-up typically 2–3/52 after          hospitalisation rates.
                                                                                   completion of XRT and then 2–4/12
                                                                                   thereafter for the first year, 6 months   At 3-month follow-up, the percentage of patients with
                                                                                   for the second and third year, and        high-grade dysphagia was 46% among those with
                                                                                   then annually. Median follow-up was       prophylactic GT placement and 27% among those who
                                                                                   30/12 (range, 6–85).                      had not received prophylactic GT placement (p = 0.01).

                                                                                   Dysphagia Ax using validated tool.        At 6 months, these percentages were 34% and 5%,
                                                                                                                             respectively (p <0.001). Notably, the proportion of
                                                                                   Outcomes:                                 patients complaining of odynophagia was essentially
                                                                                    • Survival                               zero at both 3 and 6 months, suggesting that the
                                                                                    • Wt loss                                difficulty in swallowing was not due to pain.
                                                                                    • Dysphagia
                                                                                    • PEG use                                Significant differences existed in the prevalence of long
                                                                                    • Hospitalisation                        term GT dependence after treatment (p < 0.001).
                                                                                    • Unplanned rx breaks
                                                                                    • Oesophageal stricture                  Patients who underwent radiation therapy with
                                                                                                                             prophylactic GT had a significantly higher incidence of
                                                                                                                             diagnosis of stricture compared with those who did not
                                                                                                                             have prophylactic GT placed before treatment (30% vs.
                                                                                                                             6%, p < 0.001). When the analysis was limited to the 77
                                                                                                                             patients without evidence of local-regional tumour
                                                                                                                             recurrence, the results remained statistically significant
                                                                                                                             with respect to the endpoints of high-grade dysphagia
                                                                                                                             and stricture (p < 0.05, for both).
Citation                                      Level &   Study Design & Sample          Intervention & Outcomes                  Results                                                   Comments
                                              Quality
Chen AM, Li B-Q, Jennelle RLS, et al. Late    IV Ø      Retrospective review,          Intervention (independent                Oesophageal toxicity:                                     No preRT endoscopy
esophageal toxicity after radiation therapy             Cohort study of patients at    variables):                               • 3 months:                                              performed for baseline
for head and neck cancer. Head & Neck                   different stages of disease.   Tumour site, T classification,                  - 64/211 (30%) with grade 3 late toxicity (pain    oesophageal pathology (?RT
                                                                                       concurrent chemotherapy, sex, age,              on swallow, inability to swallow solids)           cause of injury of pre-
2010;32:178-83.
                                                        California                     RT modality and technique, RT dose              - 43 pts (20%) G-tube dependent (all gde 3)        existing due to
                                                                                                                                       - median wt loss 15% of BW since pre RT for        smoking/alcohol).
                                                        N=211                          Outcomes:                                       those with gde 3 toxicity
                                                                                        • Grade 3 toxicity                       • 6 months:
                                                        T0-T4 SCC oropharynx,           • Stricture                                    - 19% had gde 3 toxicity
                                                        oral cavity, larynx,                                                           - 23 pts (11%) G0 tube dependent (all gde 3)
                                                        unknown primary,
                                                        nasopharynx, paranasal                                                  Endoscopic findings (60 pts scoped at 18 mths):
                                                        sinus/nasal cavity who                                                   • 41/60 had visible abnormality (strictures, stenosis,
                                                        received radiotherapy.                                                       oesophagitis, candidiasis)

                                                                                                                                Clinical-Pathological Correlates: (p<0.05)
                                                                                                                                 • Significant associations between grade 3 toxicities
                                                                                                                                      and:
                                                                                                                                         - hypopharyngeal primary site
                                                                                                                                         - unknown primary site
                                                                                                                                         - concurrent chemotherapy
                                                                                                                                 • Significant associations between stricture and:
                                                                                                                                         - hypopharyngeal primary
                                                                                                                                         - unknown primary
                                                                                                                                         - T4 disease
                                                                                                                                         - concurrent chemotherapy

                                                                                                                                DVH analysis:
                                                                                                                                 • Significant associations between several
                                                                                                                                    dosimetric parameters and gde 3 toxicity (IPC
                                                                                                                                    V65, CPI Dmax, CPI V60)
                                                                                                                                 • Significant associations between stricture and
                                                                                                                                    dosmetric parameters




Chencharick JD, Mossman KL. Nutritional       IV Ø      Case series, multicentre,      Pre-RT, weekly during RT                 Perceived dry mouth:                                      Age range 11-83 (?children)
consequences of the radiotherapy of head                USA                                                                     -    25% pts before RT, 80% pts at end RT
and neck cancer. Cancer 1983;51:811-5.                                                 Outcomes:                                Taste alterations – numerous changes                      Dietary intake data is of little
                                                        N=74                           Symptoms of dry mouth, abnormal          Swallowing problems:                                      usefulness – would be grossly
                                                                                       taste function, anorexia, altered food   -    40% pts pre RT, increased through RT                 under-powered but no
                                                        All pts receiving curative     preference, and dysphagia                Loss of appetite:                                         mention of statistical
                                                        courses of RT for HNC.         Weight                                   -    20% pre-RT, 60% by week 4 RT                         analysis.
                                                                                                                                Average weight loss:
                                                                                       Diet intake measured for 8 pts only.     5kg prior to RT, unchanged during RT...??
Citation                                         Level &   Study Design & Sample        Intervention & Outcomes                    Results                                                   Comments
                                                 Quality
Cheng SS, Terrell JE, Bradford CR, et al.        IV -      Cross sectional,             Part of a larger study investigating       14% (n=98) had a tube in place at the time of survey.     Unclear if current disease or
Variables associated with feeding tube                     multicentre, USA             quality of life in HNC.                                                                              old diagnosis.
placement in head and neck cancer. Arch                                                 A self-administered survey of              Multivariate analysis; factors associated with feeding
                                                           N=724                        patients at least 1 month after            tube placement (i.e. in place at time of survey!!!):      Post hoc analysis of a large
Otolaryngol Head Neck Surg 2006;132:655-
                                                                                        treatment mean 35months (range 1-          • Oropharynx/hypopharynx tumor (odds ratio [OR],          study that is of limited use in
61.                                                        Presence of cancer of head   399 months).                                   2.4;P=.01)                                            informing practice due to the
                                                           and neck (all stages, all                                               • Tumor stage III/IV (OR, 2.1; P=.03)                     study design.
                                                           treatments)-Convenience      Outcome:                                   • Flap reconstruction (OR, 2.2; P=.004)
                                                           sample of patients           enteral feeding tube in situ at the time   • Current tracheotomy (OR, 8.0; P_.001)                   “No tube” simply means
                                                           attending 4 clinics for      of the survey (Tube = NGT or               • Chemotherapy (OR, 2.6; P_.001)                          none in place at the time of
                                                           HNC.                         gastrostomy).                              • Increased age (OR, 1.3; P=.02)                          the survey – does not
                                                                                                                                                                                             represent the number of pts
                                                                                                                                   There was a curvilinear relationship between time since   that may have had one at
                                                                                                                                   treatment and feeding tube placement (sic), with about    some point.
                                                                                                                                   30% having a feeding tube at 1 month post treatment,
                                                                                                                                   tapering down during the first 3 years to about 8% and    A tube in situ 1 month after
                                                                                                                                   leveling off thereafter.                                  treatment is a very different
                                                                                                                                                                                             situation to having one in
                                                                                                                                                                                             place 399 months after
                                                                                                                                                                                             treatment and yet these have
                                                                                                                                                                                             all been pooled.

Chepeha DB, Annich G, Pynnonen MA, et            III-3 +   Retrospective quasi          Pec flap (n=108) Free flap (n=71)          Increased risk of g tube with the following:              Definition of g tube
al. Pectoralis major myocutaneous flap vs                  experimental case series +                                              • Pec flap p=0.002                                        dependence poor – what time
revascularized free tissue transfer:                       historical control           Outcome:                                   • Pre op RT p=0.004                                       point is dependence?
                                                                                        Rate of g tube dependence                  • Oropharyngeal ca p=0.01
complications, gastrostomy tube
                                                           N=179                                                                   • Stage 3-4 ca p<0.001
dependence, and hospitalization. Arch
Otolaryngol Head Neck Surg 2004;130:181-                   Pts with HN surgery
6.

Chitra S, Shyamala Devi CS. Effects of           II Ø      RCT, India                   1.   nil supplements                       Intervention group had increased salivary flow rates      Uncertain of benefits to
radiation and alpha-tocopherol on saliva                                                2.   400IU a-tocopherol                    after 6 weeks (p<0.001)                                   clinical outcomes.
flow rate, amylase activity, total protein and             N=89
                                                                                        Supplement taken daily during RT
electrolyte levels in oral cavity cancer.
                                                           Oral cavity cancer
Indian J Dent Res 2008;19:213-8.                           receiving RT                 Outcomes:
                                                                                        Saliva flow rate
                                                                                        measured at 3/52 and 6/52 post RT
Citation                                       Level &   Study Design & Sample          Intervention & Outcomes                Results                                                      Comments
                                               Quality
Connor NP, Cohen SB, Kammer RE, et al.         IV Ø      Case series, USA               Outcomes:                              Wt reduced in 89% pts – mean wt loss 9.3% 7pts had           Very small numbers (but
Impact of conventional radiotherapy on                                                                                         >10% wt loss from baseline.                                  acknowledged).
health-related quality of life and critical              N=9                            •    Weight                            Salivary function sig reduced by 1mth p 0.0003 and did
                                                                                        •    Saliva production                 not resolve by 6mths (p 0.00004).                            Detailed re swallow function
functions of the head and neck. Int J Radiat
                                                         Advanced HNC –                 •    “Diet”                            Diet impairment persisted at 6 mths (mean PSS score          but limited nutritional data.
Oncol Biol Phys 2006;65:1051-62.                         definitive or adjuvant RT                                             pre-treatment = 100, at 1 month = 60, 6mth = 80 but no
                                                                                        •    Swallow function
                                                                                        •    Auditory function                 stats).                                                      Did not choose to report on
                                                                                        •    SF-12 physical                    Swallowing abnormalities persisted at 6mths (detailed        global health status from
                                                                                        •    EORTC-QLQ                         description of features).                                    EORTC.
                                                                                                                               Auditory –modest but inconsistent changes.
                                                                                        •    C30 appetite-function
                                                                                                                               HR-QOL reduced;
                                                                                        •    EORTC QLQ- H&N 35
                                                                                                                               SF-12 physical sig reduction at 1 month p=0.05 but NSD
                                                                                             swallowing, cough, dry mouth
                                                                                                                               from baseline at 6mth.
                                                                                             symptom scales
                                                                                                                               EORTC-QLQ C30 loss of appetite-function Sig drop at
                                                                                                                               1mth(p=0.05) but NSD 6 month (p=0.59).
                                                                                        Time points:
                                                                                                                               EORTC QLQ- H&N 35( impairment compared to
                                                                                        Prior to and 1mth and 6 months after
                                                                                                                               baseline at 1mth and 6mth);
                                                                                        RT.
                                                                                                                               Swallowing p=0.024, NSD
                                                                                                                               Cough, NSD, NSD
                                                                                                                               Dry mouth p=0.003, p=0.016
                                                                                                                               (perception of xerostomia and the measurement of saliva
                                                                                                                               production were in close correspondence).
                                                                                                                               5 received gastrostomies (3 pre-RT 2 during RT).
                                                                                                                               “On the average, subjects with gastrostomy tube
                                                                                                                               placement evidenced less weight loss (mean loss of 12.5
                                                                                                                               lbs at 1 month after; 21 lbs at 6 months after) than those
                                                                                                                               without (mean loss of 29.8 lbs at 1 month after; 39.6 lbs
                                                                                                                               at 6 months after)” but numbers too small for stats.

Corry J, Poon W, McPhee N, et al.              II Ø      RCT, Australia                 1.   “push” PEG (n=15)                 At 6 weeks post-treatment, NGT vs. PEG:                      Sample potentially eligible =
Randomized study of percutaneous                                                        2.   NGT (n=18)                        •    Absolute wt (62 vs. 59 kg) NS                           97. Slow recruitment as 37%
endoscopic gastrostomy versus nasogastric                N=33                                                                  •    upper arm circumference (283 mm vs. 295) NS             refused to be randomised.
                                                                                        Insertion of a feeding tube when       •    Median wt loss 3kg vs. median wt gain 1.25kg
tubes for enteral feeding in head and neck
                                                         All pts with SCC HN            intake <50% and/or >5 kg weight             (P<0.001).                                              After 3 year - 42 randomised
cancer patients treated with                             planned for curative RT or     loss from commencement of                                                                           but 9 did not receive tube to
                                                                                                                               At 6/12:
(chemo)radiation. J Med Imaging Radiat                   CRT who were anticipated       treatment.                                                                                          which they were randomised.
                                                                                                                               •    PS (NS)
Oncol 2008;52:503-10.                                    to require enteral feeding                                            •    Response(NS)
                                                         due to:                        Baseline:                              •    Weight(NS)
                                                         - Whole or near whole          Site, TNM stage, performance status    At 6/12, those with no evidence of disease (n=26):
                                                              oral cavity irradiation   (PS), weight loss in the 3 months
                                                                                                                               •    Peg median duration of use 129days vs. NGT
                                                         - In field boost RT (an        before RT, dysphagia grade, ht,
                                                                                                                                    median duration of use 62 days P=0.0004
                                                              accelerated               weight, upper arm circumference,
                                                                                                                               Tube dislodgements:
                                                              hyperfractionated RT      TSF, nutrition requirements, QOL.
                                                                                                                               NGT n=12 vs. PEG n=0 (P=0.0001)
                                                              regimen)
                                                                                                                               Overall QOL (NS):
                                                         - CRT                          Tube insertion & 6 weeks post RT:
                                                                                                                               •    Pain was worse in PEG group for first week only
                                                         - Pts with > 10% wt            PS, ht, weight, upper arm
                                                                                                                                    P=0.03
                                                              loss before               circumference, TSF, nutrition
                                                                                                                               •    Altered body image worse in NGT group P=0.05
                                                              commencing RT             requirements, QOL and specified
                                                                                        symptoms.                              •    NGT was seen as more inconvenient than the PEG
                                                                                                                                    tube P = 0.02
                                                                                        6 months post RT:                      •    NGT interfered with social activities more than
                                                                                        PS, dysphagia grade, weight and             PEG P=0.04
                                                                                        response.                              Excluding the cost of hospitalization the total cost for a
                                                                                                                               NGT was $76 and for a PEG tube $736.
Citation                                   Level &   Study Design & Sample     Intervention & Outcomes                Results                                                   Comments
                                           Quality
Corry J, Poon W, McPhee N, et al.          III-2 Ø   Prospective cohort,       Oral intake<50% requirements and/or    At 6/52 post treatment:                                   Researchers did not discuss
Prospective study of percutaneous                    Australia                 >5kg wt loss from commencement of      •     NGT vs PEG: wt loss 3.7 vs 0.8kg P<0.001            complications beyond 6/12
endoscopic gastrostomy tubes versus                                            Rx – commenced tube feeding.           •    Pts with >10% wt loss, 18% vs. 0%                    although NG tube insertion
                                                     N=105                                                            P=0.05                                                    was up to 396 days. Issues of
nasogastric tubes for enteral feeding in
                                                                               Randomised:                                                                                      pharyngeal ulceration, tube
patients with head and neck cancer                   Pts with SCC H&N          PEG (n=22)                                                                                       blockage, discomfort may be
                                                                                                                      At 6/12 NGT vs. PEG:
undergoing (chemo)radiation. Head Neck               undergoing whole oral     NGT (n=20)                             •    Response NS                                          significant different after
2009;31:867-76.                                      cavity irradiation/                                              •    Wt NS                                                6/12. Higher % of Grade 3
                                                     hyperfractionation/ CRT   Observational:                         •    Dysphagia NS                                         dysphagia could explain
                                                     (81%). Note chemo         PEG (n=10)                             •    PS NS                                                higher chest infection rate in
                                                     regimen included          NGT (n=53)                             •    Median wt loss from tube insertion: 4.3kg vs.        PEG group.
                                                     tirapazamine.
                                                                                                                           1.0kg P=0.04
                                                                               Outcomes:
                                                                                                                      •    Numbers with > 10% wt loss. NS
                                                                               •   Adequacy of nutrition support
                                                                                                                      •    Significant difference in duration of feeding tube
                                                                                   (wt loss, % wt loss, MAC)
                                                                                                                           insertion: 57 vs. 146 days (even when excluding
                                                                               •   Complications
                                                                                                                           pts with recurrent disease) – no p value
                                                                               •   Pt satisfaction
                                                                                                                      •    More tube dislodgements in NGT P<0.001
                                                                               •   Cost
                                                                                                                      •    Significantly more infections in PEG group at PEG
                                                                               •   Mucositis                               site and/or chest infection
                                                                               •   Nutritional requirements           •    Other complications NS
                                                                               •   PS (6/12)                          •    Pain worse with PEG at insertion not 6/52 p<0.001
                                                                               •   Dysphagia (6/12)                   •    Body image worse with NGT ( p=0.03 at insertion
                                                                               •   Response (6/12)                         & 6/52), p=0.03
                                                                                                                      •    Feeds inconvenient with NGT (p,0.001)
                                                                               Measured at time of tube insertion &
                                                                                                                      •    Uncomfortable with NGT p=0.03
                                                                               6/52, 6/12 post completion of Rx.
                                                                                                                      •    Impact on family life p=0.04
                                                                                                                      •    Interfere with social activity p=0.006
                                                                                                                      •    QOL and overall physical condition NS
                                                                                                                      •    Cost: PEG= $736 vs. $76
                                                                                                                      •    Median nights in hospital= 4 (0-40) NGT vs. 14 (1-
                                                                                                                           39) PEG

Cosentini EP, Sautner T, Gnant M,          III-2 Ø   Austria                   Gastrostomy insertion via SG (n=14),   Minor complication rate:                                  High (61%) proportion of
Winkelbauer F, Teleky B, Jakesz R.                                             PEG (n=24) or PRG (n=44) method.       43% SG, 33% PEG, 36% PRG.                                 head and neck patients, BUT
Outcomes of surgical, percutaneous                   N=82                                                             Major complication rate:                                  paediatric patients were also
                                                                               Median follow up 17.2 months.          14% SG, 17% PEG, 11% PRG.                                 included. Therefore
endoscopic, and percutaneous radiologic
                                                     Patients who had a                                                                                                         applicability of the results is
gastrostomies. Arch Surg 1998;133:1076-              gastrostomy by SG, PEG    Early complications defined as < 14    Tube outcomes:                                            difficult to determine.
83.                                                  or PRG                    days post procedure.                   N=25 alive with functioning tube (1 SG, 2 PEG, 12
                                                                                                                      PRG), n=43 died with feeding tube n=4 died after tube
                                                                               Minor and major complication rates,    removal.
                                                                               tube function rates, and survival
                                                                               times.                                 Overall mortality from all causes was 47%. One death
                                                                                                                      procedure related in PRG group.

                                                                                                                      Tube function rates at 1 year were 67% SG, 68% PEG
                                                                                                                      and 10% lower in PRG group – difference not
                                                                                                                      significant.

                                                                                                                      Tube replacement rates – 28% SG (median 16d), 30%
                                                                                                                      PEG (median 15 d), 37% PRG (median 22 d).
Citation                                    Level &   Study Design & Sample     Intervention & Outcomes                 Results                                                     Comments
                                            Quality
Costa Bandeira A, Azevedo E, Vartanian J,   IV Ø      Case series, Brazil       SWAL-QOL Questionnaire                  Baseline:                                                   No nutrition data
Nishimoto I, Kowalski L, Carrara-de                                             administered to the patient by the SP         Oral diet and no tube feeding: n=28/29
Angelis E. Quality of Life Related to                 N=29                      one year post treatment including 44    Normal diet:
                                                                                questions divided into 10 domains             n=25 (86.2) with variety of diet which were hard to
Swallowing After Tongue Cancer
                                                      1 year post curative                                                    chew (steak, popcorn, Bread, salad and rice)
Treatment. Dysphagia 2008;23:183-92.                  treatment of previously   Outcome: QOL                            Soft/easy to chew diet:
                                                      untreated patients with                                                 N=3 (10%) with fruit, soft cooked vegetables,
                                                      SCC of the oral tongue.                                                 cream soups
                                                                                                                        Tube feeding only:
                                                                                                                              n=1 (3.4%)
                                                                                                                        Best liquid drunk most:
                                                                                                                              N=27 (93.1%) tea, water, milk, juice, coffee
                                                                                                                              N=2, thick liquids
                                                                                                                        Regular health status:
                                                                                                                              Poor: n=1
                                                                                                                              Fair: n=4 (13.8%)
                                                                                                                              Good: n=7 (24.2%)
                                                                                                                              Very good: n=8 (27.6%)
                                                                                                                              Excellent: n=9 (31%)

                                                                                                                        SWAL-QOL:
                                                                                                                        Worst scores:
                                                                                                                             Eating duration, mean +/- SD = 57.7+/- 45
                                                                                                                        Other scores:
                                                                                                                             Burden: mean +/- SD = 79.5+/- 26.6
                                                                                                                             Symptom frequency: mean +/- SD = 81.3+/- 19.0
                                                                                                                             Food selection: mean +/- SD = 76.3+/- 30.1
                                                                                                                             Communication: mean +/- SD =83.2+/- 17.4
                                                                                                                             Eating desire: mean +/- SD = 79.5+/- 26.6

                                                                                                                        Domains hampering swallowing:
                                                                                                                            17.2%: Dealing with my swallowing problem is
                                                                                                                            very difficult:
                                                                                                                            34.5%: It takes longer for me to eat than other
                                                                                                                            people and it takes me forever to eat a meal
                                                                                                                            27.6%: Problems chewing
                                                                                                                            20.3% Food sticking in your mouth
                                                                                                                            10.3%: fear of choking
                                                                                                                            13.8%: scared of getting pneumonia
                                                                                                                            13.8%: needing to be careful when eating
                                                                                                                            13.8%: not eating because of their swallowing
                                                                                                                            13.8%: in the way jobs and leisure’s had changed

                                                                                                                        Stratified analysis for tumour staging:
                                                                                                                              Eating duration: p=0.058
                                                                                                                              Eating desire: p=0.003
                                                                                                                              Symptom frequency: p=0.02
                                                                                                                              Communication: p=0.053
                                                                                                                              Fear: p=0.046
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                 Results                                                   Comments
                                               Quality
                                                                                                                              Stratified analysis for reconstruction in patients
                                                                                                                              compared to those that did not had worse domains for
                                                                                                                              QOL:
                                                                                                                                    Burden: p=0.007
                                                                                                                                    Eating duration: p=0.01
                                                                                                                                    Eating desire: p=0.028
                                                                                                                                    Symptom frequency: p=0.013
                                                                                                                                    Food selection: p=0.029

                                                                                                                              Stratified analysis for those that did not have
                                                                                                                              reconstruction worse domains for QOL:
                                                                                                                                    Sleep: p=0.025

                                                                                                                              Stratified analysis for those that had radiotherapy
                                                                                                                              experienced a poorer QOL with significant differences:
                                                                                                                                    Burden: p=0.007
                                                                                                                                    Eating duration: p=0
                                                                                                                                    Symptom frequency: p=0.015
                                                                                                                                    Mental health: p=0.049
                                                                                                                                    Sleep: p=0.025

                                                                                                                              Stratified analysis for time after treatment: No
                                                                                                                              association
                                                                                                                              Other scores:
                                                                                                                                    Burden: mean +/- SD = 79.5+/- 26.6
                                                                                                                                    Symptom frequency: mean +/- SD = 81.3+/- 19.0
                                                                                                                                    Food selection: mean +/- SD = 76.3+/- 30.1
                                                                                                                                    Communication: mean +/- SD = 83.2+/- 17.4
                                                                                                                                    Eating desire: mean +/- SD = 79.5+/- 26.6

Cruz I, Mamel JJ, Brady PG, Cass-Garcia        IV Ø      Case series, USA             PEG tube insertion                      208 patients had active disease
M. Incidence of abdominal wall metastasis
complicating PEG tube placement in                       N=304                        Outcome: Metastasis to the PEG          2 patients with active disease developed abdominal wall
                                                                                      tube site.                              metastasis (0.92%)
untreated head and neck cancer. Gastrointest
                                                         All patients with head and
Endosc 2005;62:708-11; quiz 52, 53.                      neck cancer who                                                      No patients with inactive disease or tumour in the
                                                         underwent PEG tube                                                   oropharynx developed metastasis to the PEG site
                                                         placement

Cunliffe DR, Swanton C, White C, Watt-         IV Ø      Case series, UK              Outcome: PEG complications              Minor wound infections at the PEG site (n=6).             There was no discussion of
Smith SR, Cook TA, George BD.                                                         Wound infection, post-operative ileus                                                             how and when enteral
Percutaneous endoscopic gastrostomy at the               N=72                         and cardio respiratory complications.   Post operative ileus (n=6).                               feeding was initiated within
                                                                                                                                                                                        this patient group, as this
time of tumour resection in advanced oral
                                                         Pts who had PEG placed                                               No cardio-respiratory complications related to PEG        would have affected fistula
cancer. Oral Oncol 2000;36:471-3.                        immediately prior to                                                 insertion were recorded.                                  and infection rates.
                                                         resection of stage IV oral
                                                         scc.
Citation                                      Level &   Study Design & Sample        Intervention & Outcomes                 Results                                                   Comments
                                              Quality
Daly JM, Hearne B, Dunaj J, et al.            II Ø      RCT, multicentre, USA        Grp 1 = intensive nasogastric feeding   •    Higher mean (range) Energy intake during RT for      2 protocol violations in each
Nutritional rehabilitation in patients with                                          (22).                                        Grp1=39kcal/kg (33-42) vs. Grp2= 30kcal/kg (28-      arm.
advanced head and neck cancer receiving                 N=35                         Grp 2 = oral & dietetic counselling          32) p<0.001.
                                                                                     (18).                                   •    Higher mean (range) protein intake during RT for     Relates to protocols used
radiation therapy. Am J Surg 1984;148:514-
                                                        Locally advanced,                                                         Grp1=1.4g/kg (1.2-1.5) vs. Grp2= 1.1 g/kg (0.6-      25yrs ago and there is a lack
20.                                                     inoperable SCC oral          Baseline, week 4, end of RT, 1mth                                                                 of clarity regarding
                                                                                                                                  1.3) p<0.01.
                                                        cavity, oropharynx,          post RT.                                •    Greater mean duration of severe toxicity for Grp1    randomisation process,
                                                        larynx, or hypopharynx or                                                 (3.3wks) vs. Grp 2 (mean1.8wks).                     insufficient stats reporting,
                                                        with primary and             Outcomes:                               •    NSD albumin between groups but both groups           typos?? With crucial data.
                                                        recurrent nasopharyngeal     •    Energy & Protein Intake                 decreased by wk 4 RT (p<0.01).
                                                        cancer receiving RT.         •    Anthropometry – Ht, wt,            •    Grp 2 decreased mid-arm muscle circumference         Check figures for nutrition
                                                                                          MAMC                                    during RT (p <0.01).                                 prescriptions.
                                                                                     •    Serum albumin                      •    NSD between groups for median field size or
                                                                                     •    Karnofsky PS (0-100)                    cumulative radiation dose.
                                                                                     •    Toxicities                         •    NSD mean change in body weight between groups
                                                                                     •    Treatment outcome/ survival             (Grp1= 3.3% vs. Grp2 = 5% loss) for primary
                                                                                                                                  NPC.
                                                                                                                             •    Lower mean weight loss in Grp1 (0.6% loss) vs.
                                                                                                                                  Grp2 (6.1%) for pts with oropharyngeal,
                                                                                                                                  hypopharyngeal, laryngeal, and recurrent
                                                                                                                                  nasopharyngeal carcinoma, as well as cancer of the
                                                                                                                                  oral cavity (p <0.04).
                                                                                                                             •    NSD between groups for Survival (? stats).
                                                                                                                             •    NSD between groups for partial or complete
                                                                                                                                  treatment response (Grp1=16/18pts vs. Grp2 =
                                                                                                                                  14/17pts).

Dawson ER, Morley SE, Robertson AG,           III-3 Ø   Comparative cohort, UK       Grp1 (n=26) = dietetic review ≤         After surgery the average weight loss for Gp1= 3.67%
Soutar DS. Increasing dietary supervision                                            fortnightly during RT, F/U at H&N       vs. Grp2 = 2.42% (P < 0.05),
can reduce weight loss in oral cancer                   N=71                         clinic >6wks post RT.                   After radiotherapy Grp1= 6.56% vs. Grp2 = 4.83% (P<
                                                                                                                             0.05),
patients. Nutr Cancer 2001;41:70-4.
                                                        SCC oral cavity surgical     Grp2 (n=45) = increased dietetic        After combined-modality treatment Grp1= 9.83% vs.
                                                        resection and post-op        supervision - Post op F/U, then         Grp2 =6.6% (P < 0.05),
                                                        radiation, consecutive pts   weighed weekly during RT –and seen      and after 1 yr NSD (but trend continued) 7.82% vs.
                                                                                     by dietitian if >2kg loss in 2wk/tube   6.6%
                                                        Grp1 = Jan1990-Dec1991       fed, dysphagia, unexplained weight
                                                        Grp2 = Jan 1996-Dec          loss. F/U within 2wk of ceasing RT      Diet texture changes in table 2 - no stats presented.
                                                        1999                         and then F/U from wk3 at H&N
                                                                                     clinic.                                 % pts with mean wt loss >10% after treatment Grp1 =
                                                                                                                             34% vs. Grp2 = 35% pts.
                                                                                     Wt = pre op, pre-RT (4wk post op),      16% Grp2 still using PEG at 1yr (4% as sole source
                                                                                     post-RT (first F/U), 1yr post           nutrition) vs. none in Grp1.
                                                                                     treatment.

                                                                                     Outcomes: Body weight, Diet
                                                                                     texture/type
Citation                                        Level &   Study Design & Sample       Intervention & Outcomes                Results                                                  Comments
                                                Quality
de Casso C, Slevin NJ, Homer JJ. The            IV Ø      Multi-centre Case series,   Total laryngectomy + RT                Swallowing (6-12 months after treatment):                Weakness of study
impact of radiotherapy on swallowing and                  UK                                                                      Solid food: n=58 / 48% (TL, n=20 /77%; TL+RT,       discussed:
speech in patients who undergo total                                                  Outcomes:                                   n=38 / 40%)                                            Retrospective in design
laryngectomy. Otolaryngol Head Neck Surg                  N=121                       • Swallowing                                Soft food: n=23 / 19% (TL, n=2 / 8%; TL+RT,            Exclusion of
                                                                                      • Voice                                     n=21 /22%)                                             pharyngolaryngectomees
2008;139:792-7.                                           SCC of the larynx treated                                               Taking fluids only: n= 25 /21%,                        with flap reconstruction
                                                          with a TL as a single                                                   Taking fluids and enteral feeding: n=17 /14% (TL,      Measurements of voice
                                                          modality treatment,                                                     n=4/15%, TL+RT, n=36 / 38%)                            and swallowing not
                                                          salvage surgery after                                                                                                          evaluated with validated
                                                          primary RT or with post                                            Independent variables that predict poor swallowing:         tools
                                                          operative RT at least 6                                                 Radiotherapy: p=0.0001                              Non conformal
                                                          months post treatment.                                                  Females=0.005                                       hypofractionated (15-20
                                                                                                                                  >Nodal stage=0.001                                  fractions) used.
                                                                                                                                                                                      No nutritional data provided.

de Luis DA, Aller R, Izaola O, Cuellar L,       II +      RCT, Spain                  Post op EN                             Immune markers – no differences seen.
Terroba MC. Postsurgery enteral nutrition in                                           I. EN+ arg + fibre
head and neck cancer patients. Eur J Clin                 N=47                        II. EN std                             Post op complications:
                                                                                      Outcomes (baseline, 7d and 14d post    General Infections IN = 21.7% STD = 16.7%
Nutr 2002;56:1126-9.
                                                          Surgery for oral and        op)                                    Local fistula – IN = 0% STD = 20.8% p<0.05
                                                          laryngeal cancers           • Immune markers                       Local wound infections – IN = 4.3% STD = 12.5%
                                                                                      • Post op complications
                                                                                      • GI tolerance                         GI tolerance – IN = 17.4% STD = 8.3%
                                                                                      • LOS                                  LOS –IN = 22.8 STD = 31.2 p=0.07
                                                                                      • Mortality at 3/12                    Mortality – IN = 13% STD = 8.3%

de Luis DA, Izaola O, Cuellar L, et al.         II +      RCT – double blind, Spain   Post op EN                             Immune markers – no differences seen between groups.     Contradictory inclusion/
Effect of c-reactive protein and interleukins                                          I. EN+ arg and fibre                                                                           exclusion criteria (excludes
blood levels in postsurgery arginine-                     N= 36                       II. EN std                             CRP decreased in both groups over time P<0.05.           wt loss<10%).
enhanced enteral nutrition in head and neck
                                                          Surgery for oral and        Outcomes (at baseline and 5d post      IL6 and TNFa in both groups did not change over time.    Short time period.
cancer patients. Eur J Clin Nutr 2003;57:96-              laryngeal cancers with wt   op)
9.                                                        loss of 5-10% in 6/12.      Immune markers (CRP, IL6, TNFa)                                                                 ? Effect of fibre.

de Luis DA, Izaola O, Cuellar L, Terroba        II +      RCT, Spain                  Post op EN                             Immune markers – no differences.                         More diarrhoea in the
MC, Aller R. Randomized clinical trial with                                            I. EN+ arg + fibre                                                                             intervention group but did not
an enteral arginine-enhanced formula in                   N = 90                      II. EN std + fibre                     GI tolerance: IN= 40% STD = 13% P<0.05                   impact on drop out rates.
                                                                                      Outcomes (baseline and day 14 post
early postsurgical head and neck cancer
                                                          Surgery for oral and        op):                                   Post op complications:
patients. Eur J Clin Nutr 2004;58:1505-8.                 laryngeal cancers.          • Immune markers                       General infections IN = 4% Group STD = 9%
                                                                                      • Post op complications                Local fistula; IN = 5% STD = 11% P<0.05
                                                                                      • GI tolerance                         Local infections: IN = 0% STD = 0%
                                                                                      • LOS
                                                                                      • Mortality at 3/12                    LOS: IN = 25.8 days STD = 35 days P<0.05

de Luis DA, Arranz M, Aller R, Izaola O,        II Ø      RCT blinded, Spain          Post op EN                             Plasma proteins and immune markers – no difference       Contradictory inclusion/
Cuellar L, Terroba MC. Immunoenhanced                                                  I. EN+ arg                            between groups.                                          exclusion criteria (excludes
enteral nutrition, effect on inflammatory                 N=29                        II. EN std                                                                                      wt loss<10%).
                                                                                      Outcomes (at peri op and post op day   Over time within groups:
markers in head and neck cancer patients.
                                                          Surgery for oral and        6)                                     Pre-albumin and transferrin increased p<0.05
Eur J Clin Nutr 2005;59:145-7.                            laryngeal cancers with wt   • Plasma proteins                      CRP + IL6 decreased p<0.05
                                                          loss of 5-10% in 6/12.      • Immune markers                       TNFa no change
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                Comments
                                              Quality
de Luis DA, Izaola O, Aller R, Cuellar L,     II Ø      RCT                         Oral nutrition support post op for 12   Plasma proteins – no differences between groups but    No true control group.
Terroba MC. A randomized clinical trial                                             weeks after d/c                         improved over time in both groups p<0.05
with oral Immunonutrition (omega3-                      N=73                         I. n-3 FA supplement
                                                                                    II. arg supplement                      Weight: N-3 = increase 4.9 p<0.05, ARG = no change
enhanced formula vs. arginine-enhanced
                                                        Surgery for oral and                                                Fat mass: n-3 = increase 2.7kg p<0.05, ARG=no change
formula) in ambulatory head and neck                    laryngeal cancers with no   Outcomes (Baseline and 3/12)            GI tolerance - 0% in each group
cancer patients. Ann Nutr Metab                         recent wt loss <5%.         • Plasma proteins
2005;49:95-9.                                                                       • Anthropometry                         General infections n-3 = 0% ARG = 8.57%
                                                                                    • GI tolerance                          Local complications : 0% in each group
                                                                                    • Post op complications
de Luis DA, Izaola O, Cuellar L, Terroba      II Ø      RCT                         Post op EN                              Plasma proteins – no change between groups but         Recruitment selection not
MC, Martin T, Aller R. Clinical and                     Spain                        I. EN+ arg (17g/d) + fibre             increased over time p<0.05                             clear.
biochemical outcomes after a randomized                                                   (1kcal/ml)
                                                        N=72                        II. EN std and fibre (1.25kcal/ml)      Anthropometry – no change between groups or overtime
trial with a high dose of enteral arginine
formula in postsurgical head and neck                   Surgery for oral and        Outcomes (Baseline and post op day      GI tolerance: IN = 22.8% STD = 21.6%
cancer patients. Eur J Clin Nutr                        laryngeal cancers.          12)                                     General infections: IN = 5.7% STD = 5.4%
2007;61:200-4.                                                                      • Plasma proteins                       Local fistula: IN = 2.8% STD = 18.9% p<0.05
                                                                                    • Anthropometry – wt, FM, FFM           Local wound infection: IN = 0% STD = 0%
                                                                                    • Post op complications                 LOS: IN = 27.9 days STD = 28.2 days
                                                                                    • GI tolerance
                                                                                    • LOS
de Luis DA, Izaola O, Aller R, Cuellar L,     II Ø      RCT, Spain                  Oral nutrition support post op for 12   Plasma proteins – no differences between groups.       No true control supplement
Terroba MC, Martin T. A randomized                                                  weeks after d/c                                                                                used.
clinical trial with two omega 3 fatty acid              N=65                         I. n-3 FA supplement (high n-3/n-      Plasma proteins – improved over time p<0.05.
                                                                                         6)
enhanced oral suplements in head and neck
                                                        Surgery for oral and        II. n-3 FA supplement (low n-3/n-       Anthropometry (wt, FFM, FM) – no difference between
cancer ambulatory patients. European                    laryngeal cancers plus wt        6)                                 groups or over time.
Review for Medical and Pharmacological                  loss >5% in 3/12.
Sciences 2008;12:177-81.                                                            Outcomes (Baseline and 3/12):           GI tolerance: high n-3 = 6.45%, low n-3 = 5.88%.
                                                                                    • Plasma proteins
                                                                                    • Anthropometry                         Infections: high n-3 = 29%, low n-3 = 15.7%.
                                                                                    • GI tolerance
                                                                                    • Post op complications                 Local wound complications - 0% both groups.
de Luis DA, Izaola O, Cuellar L, Terroba      II +      RCT - double blind, Spain   Post op EN:                             Plasma proteins:                                       Method of randomisation not
MC, Martin T, Aller R. High dose of                                                  1.   EN + Arg 20g/d (high dose) +      No change between groups                               clear.
arginine enhanced enteral nutrition in                  N=72                              fibre                             Increased over time in each group P<0.05
                                                                                     2.   EN std                                                                                   Excluded malnourished pts.
postsurgical head and neck cancer patients.
                                                        Surgery for oral and                                                Weight:
A randomized clinical trial. Eur Rev Med                laryngeal cancers.          Outcomes (baseline and day 10 post      No change between groups or over time.
Pharmacol Sci 2009;13:279-83.                                                       op):
                                                                                    • Immune markers                        Post op complications:
                                                                                    • Post op complications                 General infections IN = 23.6% vs. STD = 20.6%
                                                                                    • LOS                                   Local fistula: IN = 5.2% STD= 17.6% P=0.026
                                                                                    • GI tolerance                          Local infections: IN = 2.63% STD = 2.9%

                                                                                                                            LOS:
                                                                                                                            IN = 24.3 days STD= 36.1 days P=0.036

                                                                                                                            Diarrhoea:
                                                                                                                            IN = 7.89% STD = 5.88%
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                   Comments
                                              Quality
de Souza e Mello GF, Lukashok HP, Meine       IV Ø      Brazil                      PEG placement in the ambulatory         No mortality. Early complication rate =19.8%              Limited application of results
GC, et al. Outpatient percutaneous                                                  setting using the pull method and       Minor complication rate =17.6%                            as strict inclusion criteria for
endoscopic gastrostomy in selected head and             N=129                       Prophylactic IV antibiotics.            •   Local pain 7.4%                                       suitability of procedure as
                                                                                                                            •   Wound infection 6.6%                                  OP:
neck cancer patients. Surg Endosc
                                                        Outpatient percutaneous     Patients reviewed at days 2, 4, 7 and   •   Abdominal pain 2.9%                                   1.     Able to communicate
2009;23:1487-93.                                        endoscopic gastrostomy in   14 post operative.                                                                                       without interpretation,
                                                                                                                            •   Hematoma 0.7%
                                                        selected head and neck                                              Major complication rate =2.2%                             2.     Had a responsible adult
                                                        cancer patients.            Outcomes:                               •   Buried bumper syndrome 1.5%                                  at home,
                                                                                    • Early minor and major                 •   Early tube displacement 0.7%                          3.     Accepted and
                                                                                        complications.                      Complications not associated with age or gender.                 understood the
                                                                                    • Correlation between PEG                                                                                procedure and follow
                                                                                        procedure and age, gender, early    Increased complications in patients having PEG                   up care instructions,
                                                                                        complications and timing of         placement during or after treatment (radiotherapy, CRT    4.     Able to return to
                                                                                        PEG.                                or surgery) compared to pre treatment. p=0.05, p=0.027           hospital promptly if
                                                                                                                            respectively.                                                    complications occurred.
                                                                                                                                                                                      Complications compared to
                                                                                                                                                                                      hospitalised pts.
Deurloo EE, Schultze Kool LJ, Kroger R,       IV -      Case series, Netherlands    PRG insertion                           97% success rate                                          Follow up in 92% - Drop out
van Coevorden F, Balm AJ. Percutaneous                                              Minor and major complications,          6% major complication rate (4 early, 3 late)              accounted for.
radiological gastrostomy in patients with               N=130 procedures in 118     success rate, 30 day mortality and      15% minor complication rate (2% early, 13% late)          Differences in complication
                                                        patients                    procedure related mortality.            30 day mortality rate 17% (18/108)                        definitions between studies.
head and neck cancer. Eur J Surg Oncol
                                                                                                                                                                                      Discussed need to consider pt
2001;27:94-7.                                           Patients with an advanced   Early complication if <24hr post.       Success rate 97%, 6% major complication (bleeding         physical
                                                        primary tumour or a                                                 n=1, peritonitis n=3) 2% minor complications within 24    condition/age/disease and
                                                        recurrent head and neck                                             hrs and 13% after 24hrs. (leakage and minor infection).   treatment type. Not given any
                                                        cancer who underwent                                                                                                          details expect study
                                                        PRG.                                                                30 day mortality rate =17%: demonstrating advanced        population had advanced
                                                                                                                            disease.                                                  disease and severe treatment
                                                                                                                                                                                      – relating to high mortality
                                                                                                                                                                                      rates.
Doerr TD, Marks SC, Shamsa FH, Mathog         IV Ø      Prospective case series,    Assessment of pre-treatment zinc and    57% were malnourished pre treatment
RH, Prasad AS. Effects of zinc and                      USA                         nutritional status (Prognostic          •     21% malnourished Zinc +
nutritional status on clinical outcomes in                                          Nutritional Index PNI)                  •     36% malnourished zinc –
                                                        N=60                                                                •     30% well nourish, zinc –
head and neck cancer. Nutrition
                                                                                    Median f/up 52 months                   •     12% well nourish, zinc +
1998;14:489-95.                                         Newly diagnosed H&N                                                 Impaired zinc status associated with
                                                        cancer                      Outcomes:                               •    ↑T stage (p=0.003)
                                                                                    • Morbidity/complications               •    ↑Overall stage (p=0.01)
                                                                                    • Survival                              •    Increased treatment morbidity (p=0.03)
                                                                                                                            •    Unplanned hospitalisation (p=0.02)
                                                                                                                            •    Treatment delays (p=0.049)
                                                                                                                            Pts well nourished & zinc + had improved disease free
                                                                                                                            survival (p=0.01).

Dovsak T, Ihan A, Didanovic V, Kansky A,      IV Ø      Case series, Slovenia       All had NGF for median 9 days           Median BMI decreased T1 =23.03, T2 = 22.18, T3 =          Provided evidence of
Hren N. Influence of surgical treatment and                                         (range 5-15) post op.                   21.11 p<0.05.                                             inflammatory response post-
radiotherapy of the advanced intraoral                  N=16                                                                Albumin decreased post-op and regained.                   major head & neck surgery
                                                                                    Outcomes:                               CRP rose post-op then drops by end of RT.                 which is not surprising.
cancers on complete blood count, body mass
                                                        Advanced oral SCC (stage    BMI, Albumin, CRP                       Haemoglobin dropped post-op then regained.
index, liver enzymes and leukocyte CD64                 III/IV)                     Time points                                                                                       No discussion of dietetic
expression. Radiology and Oncology                      Surgery and post-op RT.     T1 pre-op,                                                                                        intervention other than post-
2009;43:282-92.                                                                     T2 8-26 days post-op,                                                                             op NGF.
                                                                                    T3 28-128 days post-RT
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                Results                                                   Comments
                                               Quality
Dworkin JP, Hill SL, Stachler RJ, Meleca       IV Ø      Case series, USA             Retrospective study of                 Evaluated 1-31mths post treatment (mean 13.6 months       Limitations = size, lack of
RJ, Kewson D. Swallowing function                                                     • grp1 = ≥ 12 months since             post).                                                    validated tool for describing
outcomes following nonsurgical therapy for               N=14                             treatment                                                                                    diet texture, lack of
                                                                                      • grp 2 = <12 months since             Each patient exhibited swallowing abnormalities in at     nutritional data,
advanced-stage laryngeal carcinoma.
                                                         Stage III/IV laryngeal           treatment                          least one of the seven objective functional categories    heterogeneous timing
Dysphagia 2006;21:66-74.                                 SCC                                                                 studied. Ten patients suffered from variable degrees of   combined with lack of detail
                                                         Some months following        Patient interview and retrospective    dysphagia (mild to severe), on all measures.              re SP/DN interventions since
                                                         non-surgical treatment       evaluation of FEES                                                                               treatment.
                                                                                                                             NSD (t =1.13; p > 0.10) between the two study
                                                                                      Outcomes:                              subgroups on any of these objective swallowing
                                                                                      • Swallowing Objective (FEES)          outcomes.
                                                                                      • Swallowing status subjective
                                                                                          (pre-treatment & current),         Common treatment sequelae included PEG tube
                                                                                      • Further surgical intervention        placement for nutritional supplementation, tracheostomy
                                                                                          (airway or swallowing)             placement for airway security &/or pulmonary toilet,
                                                                                      • Re-hospitalisation                   repeated episodes of aspiration pneumonia requiring
                                                                                      • Aspiration pneumonia                 hospital admission, and radiation-induced oropharyngeal
                                                                                                                             stricture.

                                                                                                                             # pts reporting current normal/near normal diet
                                                                                                                             ≥12mths grp 6/7 pts
                                                                                                                             <12mths grp 3/7 pts

Ehrsson YT, Langius-Eklof A, Bark T,           IV Ø      Case series, Sweden          Gastrostomy placement – either         Successful, n=156: Failed Insertion, n=15                     Methods of insertion
Laurell G. Percutaneous endoscopic                                                    introducer, push or pull method over                                                                 insufficient in numbers
gastrostomy (PEG) - a long-term follow-up                N=171                        years of study – all prophylactic      Method of Insertion:                                          to produce a meaningful
                                                                                      antibiotics.                               Introducer technique, n=89 (37/89 had                     effect and no RIG’s
study in head and neck cancer patients. Clin
                                                         Patients who had a PEG                                                  complications)                                            included.
Otolaryngol Allied Sci 2004;29:740-6.                    inserted with Head &         Outcomes:                                  Push technique, n=1                                       Definitions of
                                                         Neck Cancer -                    Weight every 1-2 weeks during          Pull technique, n=59 (24/59 had complications)            complications unclear.
                                                         Indications for G-tube:          RT and for 6 weeks post                Method not documented, n=7
                                                               Dysphagia                  Complications at < or > 12             Alternative tube placed in 10/15
                                                               5% weight loss of          weeks post placement – fatal,
                                                               previous pre-              severe, minor                      Duration of PEG use, n=-156:
                                                               treatment weight           Duration of PEG use                    < 12 weeks, n=39, > 12 weeks, n=112
                                                               Expected nutritional       Survival                               12 months, n=11 using PEG
                                                               problems caused by
                                                               advanced tumour                                               Survival Rate with PEG:
                                                               (stage 1V)                                                         RIP <12 weeks, 19%, RIP 6 months, n=57

                                                                                                                             Reason for PEG failure:
                                                                                                                                 Death: Needle puncture of abdominal wall –
                                                                                                                                 pneumoperitoneum and renal failure, n=2
                                                                                                                                 Cardiac arrest at time of gastroscopy, n=1
                                                                                                                                 Oesophageal stricture and bleeding and / or
                                                                                                                                 Tumour obstruction, n=8:
                                                                                                                                 Unable to puncture abdomen - ? obesity, n=2
                                                                                                                                 Vaginal reaction requiring CRP, n=1
                                                                                                                                 Respiratory problems, n=1
                                                                                                                                 Previous stomach resection, n=1
Citation                                         Level &   Study Design & Sample        Intervention & Outcomes                  Results                                                    Comments
                                                 Quality
                                                                                                                                 Complications:
                                                                                                                                    Overall complication rate, n=65 (42%)
                                                                                                                                    Fatal, n=7 (5%)
                                                                                                                                     o Procedure related, n=3, (with peritonitis, n=2
                                                                                                                                          and renal failure, n=1)
                                                                                                                                     o PEG related, n=4 (with GI bleed in n=2,
                                                                                                                                          necrotising fasciatis in n=,1, paralytic ileus,
                                                                                                                                          n=1)
                                                                                                                                     o N=3 for pull method, n=4 for introducer
                                                                                                                                          method
                                                                                                                                     o N=5 placed after RT, n=1 placed during RT,
                                                                                                                                          n=1 placed pre treatment
                                                                                                                                    Severe, n=33 (21%)
                                                                                                                                     o More likely to occur post RT (n=15), during
                                                                                                                                          RT (n=9), pre treatment (n=8), no RT n=1
                                                                                                                                    Minor, n=25 (16%)
                                                                                                                                     o Included minor leakage, abdominal pain,
                                                                                                                                          granulation tissue, problems with the PEG
                                                                                                                                          material
                                                                                                                                     o More likely to occur post RT (n=11), during
                                                                                                                                          RT (n=7). Pre RT (n=3), no RT n=3
                                                                                                                                    Complication rate in those with PEG <12 weeks
                                                                                                                                    (41%), and those with PEG >12 weeks (44%)
                                                                                                                                    No difference between method of insertion and
                                                                                                                                    complications/mortality



Ethunandan M, Rennie A, Hoffman G,               IV Ø      Retrospective case series,   No intervention                          27/32 pts had pain preceding death. 25/27 on opioid.       Nil report of impact of
Morey PJ, Brennan PA. Quality of dying in                  UK                                                                    20/32 dysphagia.                                           nutrition on QOL.
head and neck cancer patients: a                                                        Outcomes:                                6 PEG: 1 NGT (nil placed in last week of life).
                                                           N=32                         Quality of dying experience              17/32 required emergency admissions in last month –        Limited by retrospective
retrospective analysis of potential indicators
                                                                                        •    Symptoms                            mainly due to bleeding.                                    nature of study and subjective
of care. Oral Surg Oral Med Oral Pathol                    Deceased HNC pts                                                      20/32 died in hospital. 22% had relative present.          interpretation of case notes.
                                                                                        •    Place of death
Oral Radiol Endod 2005;100:147-52.                                                      •    Presence of relatives
                                                                                        •    Emergency admissions


Eustaquio M, Medina JE, Krempl GA, Hales         IV Ø      Case series, USA             Early oral feeding (n=20) -              In the early feeding group:                                Nutritional status of patients
N. Early oral feeding after salvage                                                     commenced clear fluids on day 3-5                                                                   not included – may affect
laryngectomy. Head Neck 2009;31:1341-5.                    N=29                         post op and advanced to pureed diet      LOS in pts without fistula (n=18): mean 7 days (range 5-   wound healing.
                                                                                        over the first 2 days then remained on   18 days).
                                                           Salvage laryngectomy         puree diet at home for 3 weeks.                                                                     Post-op /peri-op/ pre op
                                                           patients with follow up                                               LOS in pts with fistula (n=2): 24 days and 25 days         enteral feeds/ nutritional
                                                           from 4 months to 94          Outcomes:                                respectively.                                              intake not described.
                                                           months (mean 22 months).     •   LOS
                                                           Excluded: n=3 dependent      •   Complications                        Fistula rate 10%: (developed on day 5 and day 10
                                                           on tube feeding, and n=5                                              respectively). In the whole group of salvage
                                                           who developed fistula                                                 laryngectomy patients (n=29) – fistula rate 24%
                                                           prior to oral feeding.                                                (n=7/29).
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                  Results                                                    Comments
                                               Quality
Faias S, Cravo M, Claro I, Lage P, Nobre-      IV Ø      Case series, Portugal        PEG/DPEJ insertion using standard        No deaths within first 7 days of follow up.                Small sample size
Leitao C. High rate of percutaneous                                                   pull technique.
endoscopic gastrostomy site infections due               N=28                                                                  •  19 (68%) patients had + oropharyngeal swab and 5
                                                                                      Pre-procedure protocol:                     had a + nasal swab prior to PEG insertion.
to oropharyngeal colonization. Dig Dis Sci
                                                         Head and neck cancer         a) Nasal and oropharyngeal swabs,        • Peristomal infections diagnosed in 10 (36%) of
2006;51:2384-8.                                          patients referred for PEG    b) Mouth disinfection,                      patients within first 7 days after PEG/DPEJ
                                                         or direct percutaneous       c) Routine antibiotic prophylaxis for    • All peristomal infections occurred in patients with +
                                                         endoscopic jejunostomy       24 – 48 hours post PEG                      oropharyngeal swabs p=0.01
                                                         (DPEJ) placement.            d) Inspection of peristomal area on      • Concordance between the agent in the oropharyngeal
                                                                                      days 2,3 and 7 post                         swab and in the PEG stoma was observed in 6/10
                                                                                      Mortality within 30 days post               (60%) p=0.016
                                                                                      procedure.                               • 30 day survival was 27/28 (96.4%).
Felekis D, Eleftheriadou A, Papadakos G, et    II Ø      RCT                          Intervention:                            Group 1 vs. Group 2                                           Noted it was decided that
al. Effect of perioperative immuno-enhanced              (double-blind,               Group 1 (n=20)                                                                                         80% of study pts would
enteral nutrition on inflammatory response,              prospective)                 no IN pre-op/standard EN post-op         No significant differences were observed in the               operated for larynx or
                                                         Greece                       Subgroup analysis by:                    immunological markers between the 2 groups and 4              hypopharynx with
nutritional status, and outcomes in head and
                                                                                      Group 1a (well-nourished); Group         subgroups preoperatively or postoperatively.                  remaining 20% from oral
neck cancer patients undergoing major                    N=40 (36M, 4F)               1b (malnourished)                                                                                      cavity tumours.
surgery. Nutrition and Cancer 2010:62                                                 Group 2 (n=20)                           Significantly less major complications in Group 2             EER using HB equation,
(8);1105-12.                                             Dx HNSCC                     oral IN pre-op/IN EN post-op             compared with Group 1 (p<0.05).                               utilising ABW for HWR,
                                                                                      Subgroup analysis by:                                                                                  IBW for underweight and
                                                                                      Group 2a (well-nourished); Group         Conclusion:                                                   ABW for obese pts; AF
                                                                                      2b (malnourished)                        Peri op IN given in HNC undergoing major surgery may          1.2 if sedentary 1.3 if
                                                                                      No significant difference at baseline.   influence post operative outcomes by reducing                 ambulatory.
                                                                                      EN commenced within 24 hrs post          frequency rate of infections and wound complications.         Questionable definitions
                                                                                      op.                                                                                                    of malnutrition.
                                                                                      Outcomes:                                                                                              Small numbers in each
                                                                                      Albumin, Prealbumin, fibrinogen,                                                                       group when analysed in
                                                                                      CRP, Il6 and TNFα measured 5 days                                                                      sub-groups.
                                                                                      before and 8 days after surgery.
                                                                                      Correlations with nutritional status
                                                                                      between groups were also examined
                                                                                      (30/40 well nourished at baseline,
                                                                                      defined as <10% wt loss in 6/12
                                                                                      prior; 10/40 malnourished, defined as
                                                                                      >10% wt loss in 6/12 prior).
Feng FY, Kim HM, Lyden TH, et al.              IV +      Case series, United States   Intervention: Weekly chemotherapy        HNQOL & UWQOL                                              Chemoradiotherapy with
Intensity-modulated chemoradiotherapy                                                 with concurrent IMRT aiming to           Demonstrated acute worsening at 1 month followed by        IMRT aiming to reduce
aiming to reduce dysphagia in patients with                                           spare non involved parts of              significant improvement over time.                         dysphagia can be performed
                                                         Stage III to IV SCC of       swallowing structures – pharyngeal       HNQOL eating domain scores improved through 12             safely for OPC and has high
oropharyngeal cancer: clinical and
                                                         oropharynx, no prior         constrictors (PC’s), glottic &           months (p<0.001), then stabilised through 24 months        locoregional tumour control
functional results. Journal of Clinical                  therapy, Karnofsky           supraglottic larynx (GSL) &              (p=0.33).                                                  rates. On average, long term
Oncology 2010;28:2732-8.                                 performance status > 60,     oesophagus.                              UWQOL swallowing scores improved through 6 months          patient reported, observer
                                                         and primary therapy with                                              (p<0.001), then stabilised through 24 months (p=0.57).     rated and objective measures
                                                         CRT.                         Outcomes:                                Neither score returned to pre therapy levels.              of swallowing were only
                                                                                      Dysphagia by objective measure,          VF                                                         slightly worse than pre
                                                                                      patient and observer reported            VF scores worsened moderately at 3 months post CRT         therapy measures,
                                                                                      measures                                 (p=0.001) without significant improvement from 3 to 24     representing potential
                                                                                                                               months (p=0.31).                                           improvement compared with
                                                                                                                               VF based aspirations observed in 8 (11%) patients pre      previous studies.
                                                                                                                               therapy. Of patients without aspiration pre therapy 16 –
                                                                                                                               26% demonstrated aspiration at various post therapy
                                                                                                                               time points.
Citation                                        Level &   Study Design & Sample          Intervention & Outcomes                 Results                                                    Comments
                                                Quality
                                                                                                                                 Analysis of factors associated with post therapy
                                                                                                                                 dysphagia outcomes
                                                                                                                                 In multivariate analysis, the mean doses (PC, laryngeal
                                                                                                                                 or esophageal) were associated with all end points
                                                                                                                                 (p<0.001).
                                                                                                                                 After adjusting for mean doses and time since therapy, T
                                                                                                                                 stage and pre therapy outcomes score remained
                                                                                                                                 significantly associated with most outcomes scores.
                                                                                                                                 Neck dissection was significantly associated with the
                                                                                                                                 eating domain scores (p=0.02) and current smoking
                                                                                                                                 significantly associated with VF score (p=0.01).
Ferreira PR, Fleck JF, Diehl A, et al.          II +      RCT – double blind,            1.  Vitamin E mouthwash                 Intervention group had
Protective effect of alpha-tocopherol in head             Brazil                         2.  Placebo EPO mouthwash               •     36% reduction in incidence of mucositis (p=0.038)
and neck cancer radiation-induced                                                            (contains 2.5% vitamin E)           •     Decreased pain (p=0.0001)
                                                          N=54                           Mouthwash used before each fraction     •     No effect on survival
mucositis: a double-blind randomized trial.
                                                                                         of RT and 8-12 hr post, for duration    •     No effect on wt loss (both groups lost ~8%)
Head Neck 2004;26:313-21.                                 Ca oral cavity or              of RT. Patient assessed weekly with
                                                          oropharynx receiving RT,       median f/up 12months
                                                          tolerating solid food at
                                                          baseline.                      Outcomes:
                                                                                         • Mucositis
                                                                                         • Weight
                                                                                         • QOL – pain / difficulty eating
Fietkau R, Iro H, Sailer D, Sauer R.            III-2 -   Observational study:           134= no PEG 47=early PEG (within        Wt during RT                                               Clinical significance of wt
Percutaneous endoscopically guided                        prospective cohort ,           2 weeks of RT start),                   -    oral group mean wt loss 3kg                           loss is low: mean wt loss in
gastrostomy in patients with head and neck                Germany                        31=late PEG (excluded from              -    PEG group mean wt gain 2kg                            oral group =3kg in group
                                                                                         analysis)                               Wt post RT                                                 with mean wt of 73kg= 4.1%.
cancer. Recent Results Cancer Res
                                                          N=212                                                                  -    oral group continued to decline up to 24/52           Wide range of treatment
1991;121:269-82.                                                                         Outcomes:                               -    PEG group declined b/t 12-24/52 back to baseline      regimes with low numbers of
                                                          Advanced H&N Ca pts            Wt, mid-arm muscle circumference,            wt                                                    patients having CRT (n=13).
                                                          undergoing RT + chemo          triceps skin fold, visceral proteins    MAC stable in both groups during RT.
                                                          or surgery.                    QOL                                     Triceps skin fold inc in PEG pts and decreased in oral
                                                                                                                                 group during RT.
                                                                                         RT: wk 0,2,4,6,12,18,24                 QOL: PEG group was lower before RT but QOL did not
                                                                                                                                 drop during or after RT compared to oral group
                                                                                                                                 PEG side- effects: nil relevant observed.

Finlay PM, Dawson F, Robertson AG,              IV Ø      Case series, UK                Pre op and at 2/52, 1/12, 3/12, 6/12,   POST OP DIET (Tumour site had no significant affect)       Relevance with newer
Soutar DS. An evaluation of functional                                                   9/12, 12/12 post op.                    Solid – 54%, Semi-solid – 30%, Liquids only – 16%.         treatment protocols.
outcome after surgery and radiotherapy for                N=255                                                                  Post-Rx dietary consistency (surgery /surgery +RT)
                                                                                         Outcomes:                               p<0.001                                                    Wt data and what time point
intraoral cancer. Br J Oral Maxillofac Surg
                                                          Patients undergoing            • Body weight                           Solid                 78 / 42.2                            was median taken at.
1992;30:14-7.                                             surgical excision of oral or                                           Semi-solid            15 / 37.3
                                                                                         • Dietary consistency
                                                          oropharyngeal carcinoma.       • Dental occlusion                      Liquid                  7 / 20.5
                                                          Some pts then underwent                                                Post-Rx dietary consistency and restoration dental
                                                          RT.                                                                    occlusion: Non restored/restored p<0.005
                                                                                                                                 solid                  40.2 / 60.6
                                                                                                                                 semi-solid             33.8 / 28.2
                                                                                                                                 Liquid                 26.0 / 11.2
                                                                                                                                 Dietary consistency in pts with FOM tumours vs.
                                                                                                                                 restoration of occlusion Non restored/restored p<0.005
                                                                                                                                 solid                   23.8 / 73.7
                                                                                                                                 semi-solid              38.1 / 21.0
                                                                                                                                 Liquid                  38.1 / 5.3
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes               Results                                                    Comments
                                              Quality
                                                                                                                                  Effect of tumour stage: 6% of T1 group reported
                                                                                                                                  post-op swallowing problems vs. 21% in T2, 3, 4
                                                                                                                                  (grouped together) (P<0.001).
                                                                                                                                 93% of pts who had surgery alone reported no
                                                                                                                                 problems swallowing food of any consistency post-
                                                                                                                                 op vs. 72% in the surgery and radiotherapy group
                                                                                                                                 (P<0.001).
                                                                                                                                 Median wt loss (kg) vs. tumour classification.
                                                                                                                          T1 – 0, T2 - 4.1kg, T3 – 4.3kg, T4 – 3.2
                                                                                                                                 Regain wt vs. mode of Rx – yes/no
                                                                                                                          Surgery                  33.5/ 66.7
                                                                                                                          Surgery + RT            65.5 / 34.5
                                                                                                                          In all tumour sites, there was a tendency not to regain
                                                                                                                          pre-op wt but site was only significant in oropharyngeal
                                                                                                                          tumours where 70.6% of pts failed to do so (P<0.001).


Finocchiaro C, Galletti R, Rovera G, et al.   IV Ø      Case series, Italy          PEG placement - Pull (98%) or push    Duration of tube use:                                      Discrepancy of patient
Percutaneous endoscopic gastrostomy: a                                              (2%). All prophylactic antibiotics.        277+/- 358d, range = 31-1590                          numbers.
long-term follow-up. Nutrition 1997;13:520-             N=136
                                                                                    Follow up at day 30 and every 60      SURVIVAL:                                                  Lack nutrition data.
3.
                                                        PEG placement in cancer     days thereafter for up to 2 years.    Survival Outcome for all patients:
                                                        and non cancer patients.                                               90.5% @ one month for all patients (9.5%, n=13
                                                                                    Outcomes:                                  died <30d after PEG (6 non cancer v 7 cancer))
                                                        Cancer patients, n=63:      •   Survival                               22%, died <2 month
                                                            H&N, n=49               •   Minor PEG complications                52% @ 6 months
                                                            Oesophageal, n=9        •   Major PEG complications                42% @12 months
                                                            Other cancer, n=5                                                  35% @ 24 months
                                                                                                                          Survival Outcomes for cancer v non cancer p<0.02:
                                                        Non cancer patients, n=65                                              Higher survival 6 months - 64% non ca 39% ca
                                                                                                                               2 years: 44% non ca v 17% ca
                                                                                                                          Survival outcomes for weight:
                                                                                                                               Lower survival in patients with weight <50kg at
                                                                                                                               time 0 of study compared to heavier, (More cancer
                                                                                                                               patients <50kg v non cancer patients) p=0.002

                                                                                                                          COMPLICATIONS:
                                                                                                                          1.9% Procedure related mortality, n=2:
                                                                                                                               (day 3 + 6) in malnourished patients from
                                                                                                                               peritonitis
                                                                                                                               17.1% long term Major complications, n=22
                                                                                                                          3% Major complication, n=4:
                                                                                                                               n=1 aspiration pneumonia, n=1 subcutaneous
                                                                                                                               abscess, n=2 buried bumper syndrome
                                                                                                                          14% Minor Complications, n=18:
                                                                                                                               n=8 tube blockages, n=6 infection requiring
                                                                                                                               antibiotics, 5% constipation observed in long term
                                                                                                                               HEN
Citation                                     Level &   Study Design & Sample         Intervention & Outcomes                  Results                                                Comments
                                             Quality
Flynn MB, Leightty FF. Preoperative          III-1 Ø   Clinical trial – part         •    Well nourished (n=25) – nil pre-    59% malnourished prior to treatment – and these pts    Nutrition assessments
outpatient nutritional support of patients             randomised and part                op intervention                     have an increased LOS                                  reported at admission and
with squamous cancer of the upper                      cohort, USA                   •    Malnourished (n=36) –                                                                      discharge – but no data
                                                                                          randomised to pre-op nutrition      Complications:                                         presented.
aerodigestive tract. Am J Surg
                                                       N=61                               intervention for 10-21 days         Well nourished – not reported
1987;154:359-62.                                                                                                              Malnourished ONS 32%                                   Malnourished group had
                                                                                               o Oral nutrition
                                                       SCC upper aero-digestive                    supplements ONS            Malnourished NC 59%                                    more advanced disease and
                                                       tract for surgery                           (n=19)                                                                            extensive treatment.
                                                                                               o Nutrition counselling        LOS:
                                                       Dietitian and surgeons                      NC (n=17)                  Well nourished group 12d                               No stats.
                                                       blinded to each others                                                 Malnourished ONS 18d
                                                       assessments.                  Std care for post op nutrition           Malnourished NC 21d
                                                                                     intervention – no details
                                                                                     Outcomes (on discharge):
                                                                                      • Complications
                                                                                      • LOS


Forbes K. Palliative care in patients with   IV Ø      Retrospective case series,    No intervention                          Symptoms                                               Nil report of impact of
cancer of the head and neck. Clinical                  UK                                                                     •    74% dysphagic                                     nutrition on QOL.
Otolaryngology and Allied Sciences                                                   Outcomes:                                •    47% of admissions due to chest infections
1997;22:117-22.                                        N=38                          • Symptoms                               •    79% in pain                                       Limited by retrospective
                                                                                     • Communication                          •    53% had tracheostomy                              nature of study and subjective
                                                       HNC pts receiving             • Nutrition                              •    53% communication difficulties                    interpretation of case notes.
                                                       palliative care (79% local/                                            Nutrition
                                                       loco-regional recurrent                                                •    79% had Wt loss
                                                       disease).
                                                                                                                              •    1 PEG: 8 NG
                                                                                                                              •    5/8 NG pts had repeated tube blockages & re-
                                                                                                                                   insertions


Frowen J, Cotton S, Corry J, Perry A.        IV +      Cohort of patients at         Intervention (independent                Swallowing over 6 months post tx:                      * several swallowing
Impact of demographics, tumor                          different stages of disease   variables):                              •     Swallowing worse at 3 mths compared with         measures performed,
characteristics, and treatment factors on              (groups created post hoc      Time (baseline, 3 months post tx, 6            baseline (p<0.001).                              significant values for specific
                                                       and comparisons made).        mths post tx), sex, age, location of     •     Significant improvements between 3 mths and 6    swallowing measures, not
swallowing after (chemo)radiotherapy for
                                                                                     residence, living status, smoking              mths.                                            necessarily all measures
head and neck cancer. Head & Neck                      Melbourne                     history, alcohol history, tumour site,                                                          significant (see worksheet for
                                                                                                                              •     Swallowing at 6 mths remained worse than
2010;32:513-28.                                                                      T classification, overall stage of             baseline (p<0.001 to p=0.005).                   details of which measures
                                                       N=81                          disease, RT technique, laterality of                                                            were significant).
                                                                                     RT, length of radiation field.           Pretreatment Factors & swallowing outcomes:
                                                       T1-T4 SCC of tonsil, soft                                              •     Worse swallowing* associated with:
                                                       palate, base of tongue,       Outcomes:                                      - Rural living (p=0.007 to p=0.047)
                                                       hypopharynx, supraglottis,    Swallowing outcomes:                           - Ex-heavy drinking (p<0.001). 82% of ex-heavy
                                                       larynx underwent              (i) % of pharyngeal residue                    drinkers had supp tube feeding and severe
                                                       (chemo)RT.                    (ii) Penetration-aspiration,                   swallow limitation at 3 mths
                                                                                     (iii) Impairment and activity                  - Hypopharyngeal tumour site (p=0.001 to
                                                                                           limitation                               p=0.042). Still severe swallow limitation at 6
                                                                                     (iv) Feeding tube use                          mths, with 50% of these still on enteral feed
                                                                                                                                    - Large (T3,T4) tumours (p<0.001 to p=0.007).
                                                                                                                                    Also T4 worse than T3 (p<0.001 to p=0.012)
Citation                                   Level &   Study Design & Sample         Intervention & Outcomes         Results                                                     Comments
                                           Quality
                                                                                                                   Treatment Factors & swallowing outcomes:
                                                                                                                   •     Worse swallowing* associated with:
                                                                                                                         - Nonconformal RT (p=0.002 to p=0.045) – high
                                                                                                                         mean pen-asp scores at 6 mths and 23% (7 pts)
                                                                                                                         still enteral feed
                                                                                                                         - Bilateral RT to pharynx (p=0.001 to p=0.049) –
                                                                                                                         high risk of airway penetration at 6 mths - 13 pts
                                                                                                                         (34%) still required enteral feed
                                                                                                                         - Longer RT fields - Significant correlation
                                                                                                                         between length of RT field and swallowing
                                                                                                                         measures at 3 (p<0.01 to p<0.05) and 6 mths
                                                                                                                         (p<0.05)

                                                                                                                   Predictors of swallowing outcomes (p<0.001 to
                                                                                                                   p=0.045):
                                                                                                                        -     Previous swallowing (most common)
                                                                                                                        -     T classification
                                                                                                                        -     Alcohol history
                                                                                                                        -     RT technique

Fujimoto Y, Hasegawa Y, Yamada H, Ando     IV Ø      Case series, Japan            Outcomes:                       Factors influencing post operative swallowing:              No nutritional data with
A, Nakashima T. Swallowing function                                                • Oral intake after surgery          Age (>60 or < 60)                                      regard to % oral v enteral
following extensive resection of oral or             N=70 (final n=62)             • Quality of diet – 6/12 post        Presence or absence of segmental mandibulectomy        feeding.
                                                                                       surgery                          Extent of tongue resection/glossectomy
oropharyngeal cancer with laryngeal
                                                     Patients diagnosed with                                            Neck dissection                                        No data regarding nutritional
suspension and cricopharyngeal myotomy.              HNC and underwent                                                  Presence or absence of pre or post operative RT        status.
Laryngoscope 2007;117:1343-8.                        extensive resection of oral                                        >50Gy
                                                     or oropharyngeal cancer.                                           Method of reconstruction (free flap or pedicled)

                                                                                                                   Quality of diet:
                                                                                                                        53/62 (85%) achieved oral diet without tube
                                                                                                                        feeding
                                                                                                                        n=8 continue with NGT
                                                                                                                        n=32 (51.6%) limited to liquid diet
                                                                                                                        n=12 (19.4%) resume a normal diet

                                                                                                                   Rate for effect on achieving higher quality oral
                                                                                                                   intake:
                                                                                                                        <60yrs:
                                                                                                                        <50% tongue base resection
                                                                                                                        Reconstruction with free flap

                                                                                                                   Statistical significance for effect on achieving oral
                                                                                                                   intake:
                                                                                                                         Preoperative radiotherapy required longer tube
                                                                                                                         feeding p=0.0015
                                                                                                                         > 60 lower rate of achieving oral intake and longer
                                                                                                                         duration compared to <60 p=0.0001
                                                                                                                         Method of reconstruction (pedicled flap) p=0.0039
Citation                                      Level &   Study Design & Sample        Intervention & Outcomes               Results                                                      Comments
                                              Quality
Garcia-Peris P, Lozano MA, Velasco C, et      III-2 Ø   Comparative study            To compare measured REE via           HBE underestimated REE
al. Prospective study of resting energy                 without concurrent           indirect calorimetry (IC) with        Pts lost weight during treatment:
expenditure changes in head and neck                    controls OR                  estimated REE via Harris-Benedict     BMI decreased 24.7+4.4 to 22.3+4.2 (P< 0.001)
                                                        Case series, Spain           equation (HB) in H&N cancer pts       REE changed significantly during treatment (IC P<0.05;
cancer patients treated with
                                                                                     undergoing CRT.                       HB formula P<0.001)
chemoradiotherapy measured by indirect                  N=18                         Before CRT, 2,4&6/52, end of CRT      Decrease in visceral proteins during treatment observed
calorimetry. Nutrition 2005;21:1107-12.                                              and 2/52 post
                                                        H&N cancer (Stage III &                                            REE (IC) varied during CRT mean BMI before < BMI
                                                        IV), chemoradiotherapy       Outcomes:                             end (p 0.001).
                                                                                     • BMI (wt & ht), triceps/sub
                                                                                         scapular skinfold thickness
                                                                                         MAC, MAMC, tetra polar
                                                                                         bioimpedence
                                                                                     • Indirect Calorimetry via
                                                                                         metabolic monitor (Deltatrac II
                                                                                         MBM-200) after overnight fast
                                                                                         with REE calculated by Weir
                                                                                         formula
                                                                                     • Biochemistry

García-Peris P, Parón L, Velasco C, et al.    IV -      Prognosis case series,       Phone interview: Time since surgery   Dysphagia Prevalence 50.6%.                                  Validity of alterations made
Long-term prevalence of oropharyngeal                   Spain                        28.5+/- 17.8 months (range: 2-65)     Dysphagia to solid food was present in 72.4% patients.       to dysphagia assessment
dysphagia in head and neck cancer patients:                                                                                Dysphagia to semi-solid food in 17.2%, and liquids in        questionnaire.
                                                        N=87                         Outcomes:                             17.2%.
Impact on quality of life. Clin Nutr
                                                                                     • QOL                                 Nearly 34% had to swallow more than once to pass the         ? Markers for definition of
2007;26:710-7.                                          H&N Ca patients who had                                            entire bolus.                                                malnutrition.
                                                                                     • Nutrition status (BMI and
                                                        been treated with surgery,       albumin)                          Edentulism was present in 36.8%, Xerostomia present in
                                                        radiotherapy, and            • Dysphagia                           18.4%.
                                                        chemotherapy                                                       Odynophagia present in 11.5%.
                                                                                                                           Patients who received RT or Chemo had more
                                                                                                                           prevalence of dysphagia than those without co adjuvant
                                                                                                                           Treatment (p<0.05).
                                                                                                                           Prevalence of dysphagia related to time since surgery
                                                                                                                           was higher in the first year after surgery (63.6%) than in
                                                                                                                           subsequent years (45%).
                                                                                                                           Only 42.9% of patients with dysphagia could reach
                                                                                                                           100% of their requirements orally; 26.4% needed to
                                                                                                                           modify food texture and 26.4% required nutritional
                                                                                                                           supplements; only 2 patients required tube feeding.
                                                                                                                           Patients with maxillectomy needed less nutritional
                                                                                                                           treatment than the other surgeries (p<0.05).

                                                                                                                           Malnutrition
                                                                                                                           Malnutrition was present in 20.3% of patients (81.3%
                                                                                                                           marasmus, 6.3% PEM, 12.5% protein malnutrition).
                                                                                                                           Mean BMI 25.5 +/- 5.1 (16-41.6).
                                                                                                                           Mean plasma Alb 4.3 +/- 0.4 g/dl (2.85-6).
                                                                                                                           Patients treated with CRT had a higher risk of
                                                                                                                           malnutrition than patients without co adjuvant treatment
                                                                                                                           (p<0.05) in the first year post surgery 40.9%
                                                                                                                           malnutrition, 15% thereafter
Citation                                      Level &   Study Design & Sample         Intervention & Outcomes                  Results                                                     Comments
                                              Quality
                                                                                                                               QoL
                                                                                                                               QoL impaired due to swallowing problems in 51.7% of
                                                                                                                               patients.
                                                                                                                               62% avoided eating with other persons.
                                                                                                                               37% felt embarrassed at mealtimes.
                                                                                                                               Patients treated with Chemo or RT presented worse QoL
                                                                                                                               than patients without co adjuvant Treatment (p<0.05).
                                                                                                                               QoL was negatively affected in the first year after
                                                                                                                               surgery in 59.1% decreasing to 45% thereafter.
                                                                                                                               Patients with dysphagia presented a higher impairment
                                                                                                                               in their QoL than those without swallowing problems
                                                                                                                               (p<0.05).
                                                                                                                               Patients with total or segmental mandibulectomy had the
                                                                                                                               highest rate of malnutrition.
                                                                                                                               Patients with total glossectomy and those treated with co
                                                                                                                               adjuvant CRT in their first year after surgery had the
                                                                                                                               worst QoL.


Gardine. Predicting the need for prolonged    III-3 Ø   Prognosis, retrospective      Retrospective audit of patient medical   41/92 (37.6%) required tube feedings for more than 30
enteral supplementation in the patient with             cohort, USA                   records to determine which factors       days:
head and neck cancer. American Journal of                                             predispose the postoperative head and    •     Nasogastric tube (n=21), with n=4 complications
                                                        N=109                         neck cancer patient to long-term         •     Oesophagostomy (n=17), with n=10 complications
Surgery 1988; 156(1): 63-65.
                                                                                      dependence on tube feedings.             •     Gastrostomy (n=3), with n=1 complication
                                                        Patients treated by
                                                        surgical resection for        Post-op enteral feeding was given to     Need for prolonged enteral support was associated with
                                                        squamous cell carcinomas      92/109 (84.4%).                          p<0.001
                                                        of the oral cavity, larynx,                                            •    Stage IV cancers
                                                        or pharynx.                   Outcomes:                                •    Pharyngeal tumors
                                                                                      • Duration of enteral feeding            •    Combined therapy
                                                                                      • Preoperative weight loss               •    Preoperative weight loss of more than 10 pounds
                                                                                      • Type of feeding tube
                                                                                      • Reasons for pro longed enteral         Patients with 1 or more of these risk factors found 12/59
                                                                                          feeding                              (20.3%) required TF>30days
                                                                                      • Long term complications of
                                                                                          enteral feeding                      Patients with 2 or more of these risk factors found 29/50
                                                                                                                               (58%) required TF>30days

                                                                                                                               Reasons for prolonged TF:
                                                                                                                               •    Wound healing (n=22)
                                                                                                                               •    Inadequate oral intake
                                                                                                                               •    Oral or pharyngeal cutaneous fistulas
                                                                                                                               •    Aspiration
                                                                                                                               •    Severe mucositis
                                                                                                                               •    Pharyngeal stricture
                                                                                                                               •    Trismus
                                                                                                                               •    Severe xerostomia
Citation                                       Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                       Comments
                                               Quality
Garg S. Nutritional support for head and       I+        Systematic review and       Comprehensive hierarchical literature   •     5 trials studied dietary counselling and/or             Limited no. of RCTs
neck cancer patients receiving radiotherapy:             meta-analysis               search. Previous systematic reviews           nutritional supplements.                                addressing the clinical
a systematic review. Support Care Cancer                                             or evidence-based guidelines that       •     4 studied drug interventions.                           question of interest –
                                                         N=10 RCT’s                  addressed this topic were also          •     1 studied prophylactic enteral tube feeding.            difficulties with blinding and
2010; 18(6):667-677.
                                                                                     potentially eligible.                                                                                 ethics of withholding
                                                         N=585 (H&N only n=512)                                              Nutritional status appeared to be maintained or improved      treatment.
                                                                                     All studies randomised <50 patients     with dietary counselling, Megesterol acetate and
                                                         RCTs studying nutrition     per trial arm, (range 23-129 per        prophylactic enteral tube feeding.                            Limitations of studies in this
                                                         support interventions of    RCT).                                                                                                 population (e.g. majority of
                                                         adult patients with                                                                                                               these patients underwent RT
                                                         HNSCC; receiving either     >95% of the HNSCC patients                                                                            alone), however the mainstay
                                                         RT or CRT as a              received RT alone or after                                                                            of curative treatment is CRT.
                                                         component of definitive     neoadjuvant CT in 1 trial arm.
                                                         treatment.

Gharote HP, Mody RN. Estimation of serum       III-2 Ø   To evaluate serum leptin    Serum samples of patients with oral     Serum leptin had significant correlation with BMI in          A significant decrease in
leptin in oral squamous cell carcinoma.                  in oral squamous cell       SCC and those of healthy people         both groups.                                                  leptin levels of patients with
Journal of Oral Pathology & Medicine                     carcinoma patients and      were analysed for leptin levels.                                                                      oral SCC was found.
                                                         compare it with that of                                             A significant reduction in leptin level of oral squamous
2010;39:69-73.
                                                         healthy individuals and                                             cell carcinoma patients was observed.                         A decrease in serum leptin
                                                         correlate it with body                                                                                                            may be related to decrease in
                                                         mass index.                                                         Correlation was seen between serum leptin levels of           body fat mass.
                                                                                                                             various pathological variants of oral squamous cell
                                                         N=31oral squamous cell                                              carcinoma.
                                                         carcinoma patients
                                                         N=28 healthy individuals

Gibson S, Wenig BL. Percutaneous               III-2 Ø   Comparative cohort study,   Compared patients who had PEG           Length of hospital stay:                                      Other variables not accounted
endoscopic gastrostomy in the management                 retrospective, USA          (n=43) tube placed pre-op using pull    •    Oral cavity, tongue base NS                              for (only matched for primary
of head and neck carcinoma. Laryngoscope                                             technique to those with NGT (n=46).     •    Tonsil (48 days for NGT and 19 days for PEG) =           disease and stage).
                                                         N=89                                                                     60% reduction.
1992;102:977-80.
                                                                                     Outcomes:                               •    Larynx (54 days for NGT and 21 days for PEG), =          Lack of information on
                                                         Patients hospitalised for   •    LOS                                     61% reduction.                                           duration of feeding and
                                                         primary resection of head   •    Ability to provide HEN             •    Stage II NS                                              criteria for HEN ability.
                                                         and neck SCC requiring      •    Surgical complications             •    Stage III (48 days for NGT and 28 days for PEG),
                                                         post op enteral feeding.    •    Feeding tube related                    = 42% reduction.
                                                                                          complications                      •    Stage IV (58 days for NGT and 25 days for PEG),
                                                                                                                                  = 57% reduction.
                                                                                                                             HEN: 63% PEG,15% NGT

                                                                                                                             Surgical complication rate:
                                                                                                                             •    Primary site, stage II/III NS
                                                                                                                             •    Stage IV (fistulisation rate 42% for NGT and 25%
                                                                                                                                  for PEG)

                                                                                                                             Tube related complications:
                                                                                                                             PEG: 2/43 site infection
                                                                                                                             NGT: 41/43 complications (10 dysphagia, 6 sinusitis, 1
                                                                                                                             nasal deformity, 18 reinsertions, 4 reinsertions > 2 times,
                                                                                                                             2 inability to insert)
Citation                                     Level &   Study Design & Sample        Intervention & Outcomes               Results                                                    Comments
                                             Quality
Gibson SE, Wenig BL, Watkins JL.             III-2 -   Retrospective chart          Patients in the head and neck group   Successful PEG placement achieved 334/349 patients.        Poor statistical methods.
Complications of percutaneous endoscopic               review, comparative          (n=114) were compared to a control
gastrostomy in head and neck cancer                    cohort study, USA            (neurologic disease) group (n=220)    Failure to place PEG:                                      Poor definition of nutritional
                                                                                    for success of PEG insertion and      N= 8 (7%) head and neck n=7 (3%) neurologic                status – measured by
patients. Ann Otol Rhinol Laryngol
                                                       N=349                        complications.                                                                                   haematocrit and albumin.
1992;101:46-50.                                                                                                           Post op complication rate:
                                                       Patients undergoing PEG      Outcomes:                             •     N=31(14%) neurologic
                                                       placement.                   •   Success of PEG insertion.         •     N= 6(5%) head & neck
                                                                                    •   Gastrostomy related
                                                                                        complications.                    No difference between the groups for nutritional status
                                                                                    •   Major and minor post procedure    NS.
                                                                                        complications.




Goguen LA, Posner MR, Norris CM, et al.      IV Ø      USA                          G tube placement after IC             Nutrition                                                  Earlier recognition and
Dysphagia after sequential chemoradiation              N=59                                                               Pre treatment weight loss: (35/59 patients)                aggressive management of
therapy for advanced head and neck cancer.                                          Outcomes:                                   N=20 no weight loss                                  dysphagia and
Otolaryngol Head Neck Surg 2006;134:916-               Previously untreated         • Swallow function                          N=15 wt loss 0-27 kg: mean 4kg, median 0kg           implementation of swallow
                                                       advanced staged 3 or 4       • Nutrition – wt loss, G tube         Weight loss after completion of CRT:                       rehabilitation.
22.                                                    HNC without distant                                                      -9.6kg (+3.6kg to -29.7kg)
                                                                                        removal
                                                       metastasis having protocol   • QoL                                       Median 12.7% (+7.5% to -28.6%)                       Poor nutrition data.
                                                       based sequential CRC                                               G-tube dependence and diet at end of CRT:
                                                       (induction chemo then                                                    3 months (17% soft or regular diet, 73% G-tube)      Lack definition for g tube
                                                       concurrent CRT).                                                         6 months (53% soft or regular diet, 53% G-tube)      insertion and removal.
                                                                                                                                9 months (70% soft or regular diet, 20% G-tube)
                                                                                                                                12 months (80% soft or regular diet,19% G-tube)
                                                                                                                                Time of analysis (93% soft or regular diet, 3% G-
                                                                                                                                tube – n=2 with one patient diagnosed with
                                                                                                                                recurrence and the other choosing to keep G-tube
                                                                                                                                in situ)
                                                                                                                          Time to G tube removal:
                                                                                                                                21 weeks: median after CRT (range = 1 - 218
                                                                                                                                weeks)
                                                                                                                          Swallow Function
                                                                                                                          Pre treatment|:41% described dysphagia or
                                                                                                                          odynophagia
                                                                                                                          MBS results:
                                                                                                                                23/59 patients had MBS, median time =3.5months
                                                                                                                                after treatment
                                                                                                                                Aspiration (n=18 with n=8 silently), penetration
                                                                                                                                (n=4)
                                                                                                                                14/59 pharyngo-oesophageal narrowing with 14%
                                                                                                                                requiring dilatations
                                                                                                                          QoL: FACT H&N:
                                                                                                                          Pre-Treatment:
                                                                                                                                Swallow function scores: 3.2 (scale = 0-4) Quiet a
                                                                                                                                bit of satisfaction with swallowing and diet
                                                                                                                          Post-Treatment:
                                                                                                                                44% response rate
                                                                                                                                Swallow function scores: 2.0 (scale = 0-4)
                                                                                                                                somewhat satisfaction with swallowing and diet.
Citation                                        Level &   Study Design & Sample        Intervention & Outcomes                 Results                                                    Comments
                                                Quality
Gokhale AS, McLaughlin BT, Flickinger           III-3 Ø   Retrospective cohort         Retrospective review of patients who    33 (41%) patients required a FT, 15 before and 18
JC, et al. Clinical and dosimetric factors                study, USA                   required a FT > 6 months. Clinical      during CRT.
associated with a prolonged feeding tube                                               and dosimetric factors compared         15 (19%) of these patients required FT for > 6 months.
                                                          N=80                         between those who required FT > 6       47 patients did not require a FT at any time.
requirement in patients treated with
                                                                                       months and those who didn’t.            4 patients excluded who developed progressive/
chemoradiotherapy (CRT) for head and neck                 Patients treated with                                                recurrent disease.
cancers. Ann Oncol 2010;21:145-51.                        concurrent CRT with                                                  On univariate analysis:
                                                          curative intent for cancer                                           T3-T4 disease found to be a significant factor for
                                                          of the head and neck of                                              prolonged FT (p=0.023).
                                                          any histology.                                                       No other clinical factors associated with prolonged FT.
                                                                                                                               Mean PC dose found to be a significant factor for
                                                                                                                               prolonged FT use (p=0.047).
                                                                                                                               Percentage of the PC muscles treated was found to be a
                                                                                                                               significant factor for prolonged FT. Both 60% and 70%
                                                                                                                               PC muscles treated (PC-V60 and PC-V70 respectively)
                                                                                                                               were significant factors for prolonged FT use (p=0.031
                                                                                                                               and p=0.008 respectively).
                                                                                                                               Mean SGL dose was a significant factor for prolonged
                                                                                                                               FT use (p=0.048).
                                                                                                                               Percentage SGL treated also significant for SGL-V70
                                                                                                                               (p=0.046).
                                                                                                                               No other dosimetric factors were significant.
                                                                                                                               On multivariate analysis:
                                                                                                                               Only PC-V70 and T3-T4 disease remained significant.
                                                                                                                               Cox proportional hazards model: T3-T4 p=0.036, PC-
                                                                                                                               V70 P=0.078.
                                                                                                                               Logistic regression: T3-T4 p=0.057, PC-V70 p= 0.039.

Goldwaser BR, Chuang S-K, Kaban LB,             III-2 Ø   Retrospective cohort         ORN n= 41                               Factors associated with ORN risk:                          Limits of study design and
August M. Risk factor assessment for the                  study, USA                   No ORN n= 41                            •      Radiation dose > 66 Gy (p=0.027)                    sample size acknowledged.
development of osteoradionecrosis. J Oral                                                                                      Factors associated with decreased risk:
                                                          N=82                         Reviewed variables;                     •      Higher BMI (p=0.019)
Maxillofac Surg 2007;65:2311-6.
                                                                                       1. Patient related                      •      Steroid use pre-treatment (p=0.017)
                                                          Patients with history of     2. Health status                        On multivariate analysis for every one point increase in
                                                          H&N Ca who received RT       3. Dental                               BMI, ORN risk decreased by 27% (RR = 0.73).
                                                          from 1984-2005.              4. Tumour related                       Compared with underweight patients, risk of ORN
                                                                                       5. Treatment related                    decreased by:
                                                                                       6. Trauma related                       •      50% if normal BMI,
                                                                                                                               •      43 % if overweight (p=0.03)
                                                                                                                               •      37% if obese
Goncalves Dias MC, de Fatima Nunes              III-2 Ø   Comparative cohort study,    Patients were counseled to maintain a   Caloric and protein ingestion increased significantly in   No discussion of tumour
Marucci M, Nadalin W, Waitzberg DL.                       Brazil                       caloric ingestion of 40kcal/kg and      all 3 groups (p<0.001) with the greatest difference seen   location other than H&N
Nutritional intervention improves the caloric                                          1.5g protein/kg in one of 3 groups:     in the tube feeding group.                                 cancer.
and proteic ingestion of head and neck                    N=64                         • Oral (n=32) diet group;
                                                                                       • Feeding tube group (exclusively)      No significant difference in anthropometric or
cancer patients under radiotherapy. Nutr                  Head and neck cancer                                                 biochemistry measures was found with the exception of
                                                                                            (n=16). Tubes placed when oral
Hosp 2005;20:320-5.                                       patients undergoing post          diet < 2/3 requirements.           Total Lymphocytes which decreased significantly in all
                                                          op RT                        • Oral supplement group (n=16),         3 group post RT.
                                                                                            oral diet + supplements when
                                                                                            oral diet < 75% requirements.
                                                                                       Outcomes:
                                                                                       Caloric/protein ingestion;
                                                                                       anthropometry (wt, BMI, TSF,
                                                                                       MAMC); biochemistry.
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                   Results                                                 Comments
                                               Quality
Goodwin WJ, Jr., Torres J. The value of the    IV Ø      Case series, USA             Baseline PNI score                        Severe malnutrition (higher PNI) associated with        Retrospective calculation of
prognostic nutritional index in the                                                   Group 1 – good nutrition (PNI 0-          • Slightly older age                                    PNI - ?validity (utilises
management of patients with advanced                     N=50                         19%) n=18                                 • More advanced disease                                 albumin, transferrin, TSF,
                                                                                      Group 2 – mild malnutrition (PNI 20-      • Complications with each modality of treatment         delayed hypersensitivity).
carcinoma of the head and neck. Head Neck
                                                         Stage 3, 4 or recurrent      39%) n=18                                     p<0.0001
Surg 1984;6:932-7.                                       SCC of H&N                   Group 3 – severe malnutrition             • Mortality p < 0.01
                                                                                      (PNI>39%) n=14
                                                                                                                                Pre-op nutrition support:
                                                                                      1 year                                    • 6/9 pts received pre-op nutrition support
                                                                                      • Complications                           • 3/9 patients did not receive preoperative nutrition
                                                                                      • Disease status                              support and all suffered major complications
                                                                                      • Surgical mortality

                                                                                      14 d pre-op nutrition support (EN/
                                                                                      TPN) in group 3.

Gunn GB, Endres EJ, Parker B, Sormani          IV Ø      Case series, USA             A three-dose level simultaneous           Mean wt loss during treatment was 10.6%.                PEG insertion “when
MP, Sanguineti G. A phase I/II study of                                               integrated boost IMRT strategy was        PEG placed in 15 patients (60%).                        clinically indicated’.
altered fractionated IMRT alone for                      N=25                         used, delivering 78, 69, and 60 Gy to                                                             A percutaneous endoscopic
                                                                                      gross disease, high-risk and low-risk     11 pts needed peg feeds for 3 months and 4 needed it    gastrostomy tube was
intermediate T-stage oropharyngeal
                                                         Patients with T3 or          target areas, respectively, in 60 twice   until 10 months.                                        temporarily placed in 60% of
carcinoma. Strahlentherapie und Onkologie                unfavourable T2              daily fractions over 6 weeks. No                                                                  patients during or shortly
2010;186:489-95.                                         oropharyngeal squamous       sequential/concomitant systemic           Grade 3 toxicity prevalence rates of 0.9% (2yr) and     after treatment end. Most
                                                         cell carcinoma were          treatment or up-front radical surgery     26.1% (3 years).                                        swallowing problems
                                                         eligible.                    was allowed.                                                                                      improved with time, as did
                                                                                                                                                                                        salivary function.
                                                                                      Outcomes:
                                                                                      •   Treatment tolerability
                                                                                      •   Tumour control
                                                                                      •   Toxicity

Guo CB, Ma DQ, Zhang KH. Applicability         IV Ø      Case series, China           Patients divided into two groups          Complications P<0.01                                    Uses GNS score to assess
of the general nutritional status score to                                            according to their GNS scores at time     Group 1 (well nourished), 19.4%                         nutrition – uncertain validity
patients with oral and maxillofacial                     N=127                        of diagnosis.                             Group 2 (undernourished), 48.3%                         of this measure. Combines
                                                                                      1) Good nutrition (n=81)                                                                          malnourished with under
malignancies. Int J Oral Maxillofac Surg
                                                         Previously untreated         2) Undernourished (n=46) – of             Length of Stay P<0.05                                   nutrition /risk of malnutrition.
1994;23:167-9.                                           primary oral and                  which 16 were malnourished           Group 1: 33 + 13 days
                                                         maxillofacial                                                          Group 2: 40 + 16 days                                   Does not report on RT pts.
                                                         malignancies– treated with   Outcomes:
                                                         surgery (76%) or             Post op complications                                                                             Does not address aim of
                                                         radiotherapy (24%).          LOS                                                                                               paper.

Guo CB, Zhang W, Ma DQ, Zhang KH,              III-3 Ø   Case control diagnostic      Hand grip strength measured to            Malnourished: 44/127 (35%)
Huang JQ. Hand grip strength: an indicator               and observation, China       diagnosed malnutrition (hand grip         Well nourished: 83/127 (65%)
of nutritional state and the mix of                                                   strength less than 85% of the control
                                                         N=127                        mean).                                    Complications P<0.004
postoperative complications in patients with
                                                                                                                                Malnourished 48% Well nourished 18%
oral and maxillofacial cancers. Br J Oral                Previously untreated         Outcomes:
Maxillofac Surg 1996;34:325-7.                           primary oral and             •   MAMC                                  LOS p=0.002
                                                         maxillofacial cancer         •   Creatinine ht index.                  Malnourished 42+ 20days Well nourished 32+ 10 day
                                                         (96 surgery, 31 RT).         •   Complications
                                                                                      •   LOS
Citation                                        Level &   Study Design & Sample        Intervention & Outcomes                  Results                                                     Comments
                                                Quality
Guo CB, Ma DQ, Zhang KH, Hu Xh.                 IV Ø      Case series, China           Pre-treatment nutritional assessment     Nutritional Status (Baseline)
Relation between nutritional state and                                                 •     Diet/wt history                    Well nourished n=47
postoperative complications in patients with              N=96                         •     Physical, wt, anthropometry,       Fair n=20
                                                                                             function                           Poor/malnourished n=29
oral and maxillofacial malignancy. British
                                                          Patients with previously     •     Lab values                         Complications n=27/96 (28%)
Journal of Oral and Maxillofacial Surgery                 untreated primary oral and                                            Pre-op nutrition status
2007;45:467-70.                                           maxillofacial malignancy.    Post op nutritional assessment           More malnourished pts in the complication group 15/27
                                                                                       repeated day 7 post op including N       (56%) compared to malnourished pts in the no
                                                                                       balance.                                 complication group 14/69 (20%) P<0.001
                                                                                                                                Post op nutrition status
                                                                                       Outcomes:                                Pts with complications had significantly more severe
                                                                                       Postoperative Complications -Minor       nutritional depletion (wt, anthropometry, n balance) than
                                                                                       And Major – and their relationship to    those who did not have complications P<0.05
                                                                                       nutritional status and extent of         Post op nutrition intake
                                                                                       surgical procedure.                      Pts with complications had mean intake 5.4g protein and
                                                                                                                                1095kcal per day.
                                                                                                                                Pts with no complications had mean intake 7.2g protein
                                                                                                                                and 1514kcal per day P<0.001.
                                                                                                                                Other clinical outcomes
                                                                                                                                Major procedures and blood loss no different between
                                                                                                                                groups NS.


Gutt CN, Held S, Paolucci V, Encke A.           IV Ø      Case series, Germany         PEG placement using the pull             Average procedure time was 17 minutes.                      Poorly reported study lacking
Experiences with percutaneous endoscopic                                               technique.                               Procedure related mortality 0%.                             a clear aim, methodology and
gastrostomy. World J Surg 1996;20:1006-8;                 N=115                                                                 Intra-operative complication rate 0%.                       outcomes. Outcome measures
                                                                                       Outcomes:                                Major complications 0%.                                     were not clearly defined i.e.
discussion 108-9.
                                                          Prospective study of 115     • Average procedure time                 Intra-operative technical problems in 14/115 patients and   no definition of what
                                                          patients undergoing PEG      • Intra-operative complication rate      PEG placement not possible in these cases.                  constitutes a major or minor
                                                          placement - 93.9% cancer     • Intra-operative technical              Post operative complications included local pain (40%),     complication or how long
                                                          patients, 89 (77.4%) had         problems                             site infection (19%), tube dislocation (1.8%), tube         post PEG patients were
                                                          tumours of the               • Post operative complications           blockage/ leakage (0.9%), gastric erosion (2.6%) and        followed. Conclusion was
                                                          oropharynx, 16 with                                                   gastric ulcer (1.8%).                                       subsequently vague.
                                                          obstructive oesophageal
                                                          tumours and 3 with cancer
                                                          cachexia.

Halyard MY, Jatoi A, Sloan JA, et al. Does      II +      RCT, double blind, multi-    1.   Zinc sulfate 45mg orally tds        Intervention group had non significant increased time to    High attrition rates 43%
zinc sulfate prevent therapy-induced taste                centre, USA                       after meals                         taste changes developing (2.3 vs. 1.6 weeks) and had no     completed in zinc arm, and
alterations in head and neck cancer patients?                                          2.   Placebo                             effect on taste recovery.                                   49% completed in placebo
                                                          N=173                                                                                                                             arm. Main reasons – declined
Results of phase III double-blind, placebo-
                                                                                       Supplement commenced with 7 days         No effect on QOL                                            treatment, adverse events.
controlled trial from the North Central                   Oral cavity cancer pts       of start of RT and continued daily for   99% of zinc pts maintained wt compared to 92% placebo
Cancer Treatment Group (N01C4). Int J                     receiving RT.                4 weeks post RT. Patient assessed        (p=0.04)
Radiat Oncol Biol Phys 2007;67:1318-22.                                                weekly during RT and 1,2,3,6 months
                                                                                       post.

                                                                                       Outcomes:
                                                                                       •   Pt report taste alterations
                                                                                       •   QOL
                                                                                       •   Weight
Citation                                         Level &   Study Design & Sample         Intervention & Outcomes                Results                                                      Comments
                                                 Quality
Hatoum GF, Abitbol A, Elattar I, et al.          III-2 Ø   Prospective non-              All pts were offered PEGs.             No diff in feeding dependence at 6, 12 or 18 months.         High proportion of patients
Radiation technique influence on                           randomised cohort study,                                             NS                                                           still requiring PEG feeding at
percutaneous endoscopic gastrostomy tube                   USA                           1. A3 protocol= accelerated-                                                                        18 months post treatment.
                                                                                         concomitant boost RT with TPF          62 & 65% ( 6/12),
dependence: Comparison between two
                                                           N=55                          (taxol, cisplat and 5-FU), n=35        29 and 32% (12/12)
radiation schemes. Head Neck 2009;31:944-                                                2. 4 protocol = hyperfractionated RT   26 and 32% (18/12)
8.                                                         Locoregionally advanced       with weekly carboplatin + paclitaxel
                                                           Stage III or IV H&N SCC       (n=20)                                 Survival not different NS.
                                                           from oral cavity,
                                                           oropharynx, nasopharynx,      Outcomes: Survival, PEG
                                                           paranasal sinuses or          dependence
                                                           larynx, undergoing CRT        f/up from 1-44 months

Hearne BE, Dunaj JM, Daly JM, et al.             II Ø      Prospective randomized        Randomised to tube or oral diet.       Pre –XRT, nasopharyngeal cancer pts had less wt loss         Good explanation of
Enteral nutrition support in head and neck                 trial.                                                               than other group (-2.65 to 9.8%) - significant( p=0.008).    randomisation and drop outs
cancer: tube vs. oral feeding during radiation                                           14 N/g tube fed ( 2 refused tube) to                                                                and changes to protocol
                                                           Patients were stratified      achieve oral plus tube feed=           No difference in side effects or albumin between tube        required. Groups were similar
therapy. J Am Diet Assoc 1985;85:669-74.
                                                           first according to site of    40kcal/kg, 1g PRO/kg.                  fed and oral diet.                                           at baseline.
                                                           ca, previous treatments,
                                                           and previous surgery. This    12 oral ( 2 required tube) seen bi-    Tube fed group had higher energy (35-42kcal/kg               No significance levels for
                                                           was to obtain even pt         weekly during XRT.                     compared to 15-34kcal/kg) and higher protein intake (        energy and protein intakes, or
                                                           distribution between                                                 1.2-1.6g/kg compared to 0.3-1.3g/kg) than oral diet.         side effects/toxicities or
                                                           groups.                                                                                                                           albumin.
                                                           Stage III and IV                                                     Nasopharyngeal Ca no difference oral vs. N/g.
                                                           unresectable Ca                                                                                                                   Blinding of subjects and
                                                           nasopharynx, larynx,                                                 Significant less wt loss with N/g feeding for                therapists could not be
                                                           oropharynx, hypopharynx                                              oropharyngeal and recurrent nasopharyngeal Ca                achieved.
                                                           and oral cavity having O/P                                           (p=0.005, (p=0.05, 0.2 + 5.9 vs. -7.3 + 4.2 kg.).
                                                           XRT for 6-8/52.

                                                           Intention to treat analysis
                                                           N=31
Heber D, Byerley LO, Chi J, et al.               IV Ø      Case series, USA              28 day inpatient metabolic ward stay   Wt maintenance                                               Unclear outcomes.
Pathophysiology of malnutrition in the adult                                             - continuous EN                        Anabolic:
cancer patient. Cancer 1986;58:1867-73.                    N=6                           7days @ 125% BEE (wt maintenance       Increased urinary urea nitrogen excretion, dietary protein
                                                                                         goal)                                  intake and serum urea nitrogen.
                                                           Patients with H&N Ca          19 days @ 225% BEE (anabolic           No change to protein breakdown rate or glucose
                                                           without metastatic disease.   goal)                                  production rate.
                                                                                                                                Insulin secretion and sensitivity improves.
                                                                                         Outcomes: Nitrogen balance, Whole
                                                                                         body glucose production, Insulin
                                                                                         secretion/ sensitivity to insulin
                                                                                         Weight, Protein/nitrogen intake

Hsieh JS, Wu CF, Chen FM, Wang JY,               IV Ø      Case series, Taiwan           LWG placement and follow up 30         100% success rate with LWG
Huang TJ. Laparoscopic Witzel                                                            days post placement.                   0% major complications
gastrostomy--a reappraised technique. Surg                 N=48                                                                 11% minor complications
                                                                                         Outcomes:                              0% tube disturbances (n=40 discharged from hospital)
Endosc 2007;21:793-7.
                                                           Stenotic head and neck or      • Success rate of procedure           Average duration of use 6.3 + 5.3 months (1 – 20).
                                                           oesophageal cancer             • Major and minor complications       Termination of the gastrostomy was due either to death
                                                           requiring laparoscopic         • Tube disturbances                   of the patient (n=4, disease related deaths) or removal of
                                                           Witzel gastrostomy             • Fate of tube                        tube.
                                                           (LWG) insertion.
Citation                                       Level &   Study Design & Sample          Intervention & Outcomes                   Results                                                      Comments
                                               Quality
Hujala K, Sipila J, Pulkkinen J, Grenman R.    IV -      Case series, Finland           PEG placement                             Acute complication rate of 1.3%
Early percutaneous endoscopic gastrostomy                                                                                         Late complication rate of 15%
nutrition in head and neck cancer patients.              N=79                           Outcomes:
                                                                                        Acute and late complications
Acta Otolaryngol (Stockh) 2004;124:847-
                                                         Newly diagnosed upper
50.                                                      aerodigestive tract tumour
                                                         requiring PEG insertion.
Hutcheson KA, Barringer DA, Rosenthal          IV Ø      Case series, USA               Dysphagia measured by:                    MBS studies:
DI, May AH, Roberts DB, Lewin JS.                                                           MBS                                         < 6 months post treatment, n=23
Swallowing outcomes after radiotherapy for               N=40                               Aspiration                                  6-11 months post treatment, n=15
                                                                                            Feeding Tube Dependency                     12 months post treatment, n=7
laryngeal carcinoma. Arch Otolaryngol
                                                         Laryngeal cancer patients                                                Structural abnormalities
Head Neck Surg 2008;134:178-83.                          who underwent definitive       Measured at:                              Stricture - n=3/32 (9%)
                                                         radiotherapy for stage III         < 6 months                            Pharyngeal phase disorders significant, p=<0.001
                                                         or IV.                             6-11 months                           Aspiration:
                                                                                            12 or more months                           n=27/32 (87%)
                                                                                                                                        n=12/27 (44%) silently aspirated
                                                                                                                                  Swallowing Strategies:
                                                                                                                                        70% of patients benefited
                                                                                                                                  Feeding tube dependence: Incidence:
                                                                                                                                        n=27/40 with swallowing problems prior to
                                                                                                                                        treatment
                                                                                                                                        n=31/40 (78%) required TF during course of
                                                                                                                                        treatment
                                                                                                                                  Before treatment: n=6/40 tube fed with n=4 PO + TF,
                                                                                                                                  n=2 TF + NBM.
                                                                                                                                  During treatment: median placement at 3.4 weeks
                                                                                                                                  Tube removal: n=16/31 (52%) with median @ 22 weeks
                                                                                                                                  Disease free at final follow up:
                                                                                                                                        Lower rates of tube dependency compared to those
                                                                                                                                        with recurrence/ required salvage surgery, p=0.049
                                                                                                                                        n=13/18 (72%|) maintained with oral nutrition
                                                                                                                                  Predictors of Post Treatment aspiration:
                                                                                                                                        Pre treatment dysphagia and feeding tube
                                                                                                                                        dependency not significant, p=>0.5
                                                                                                                                        Pre treatment + post treatment levels of feeding
                                                                                                                                        tube dependency significant, p=0.3
                                                                                                                                        Pre treatment aspiration with thin liquids
                                                                                                                                        significantly dependant on tube feeding and NBM
                                                                                                                                        at final assessment, p=0.1
Isenring EA, Capra S, Bauer JD. Nutrition      II +      RCT, Australia                 Randomised to receive either:                   NI (mean -0.4kg) maintained body wt over 12 wks        Noted study population mix
intervention is beneficial in oncology                                                  Grp 1 (n=29) = intensive                        compared to UC (mean -4.7kg) (P <0.001).               of both H&N and GI patients.
outpatients receiving radiotherapy to the                N=60                           individualised nutrition counselling            Significantly more in NI group i.e. 13 (24%) were
                                                                                        by a Dietitian using a standard                 wt stable than UC group i.e. 6 (11%) (P <0.016).
gastrointestinal or head and neck area. Br J
                                                         All outpatients                protocol and oral supplements if                Changes in FFM clinically but not statistically
Cancer 2004;91:447-52.                                   commencing at least 20#        required or                                     significant: NI mean gain +0.5kg, UC mean loss -
                                                         RT to GI or H&N area at a      Grp 2 (n=31) = the usual practice of            1.4kg (P=0.195)
                                                         private Australian             the centre (general advice and                  Less deterioration in nutritional status in NI group
                                                         radiation oncology facility    nutrition booklet).                             (P=0.02).
                                                         during a 12-month period       Outcomes: Body weight, body
                                                         were eligible for inclusion.   composition, nutritional status, global   NI group had significantly smaller decline and faster
                                                                                        QoL, physical function.                   recovery in global QoL (P=0.0009) and physical
                                                                                        Time points: baseline and 4, 8 and        function (P=0.012).
                                                                                        12 weeks after RT.
Citation                                      Level &   Study Design & Sample          Intervention & Outcomes                  Results                                                     Comments
                                              Quality
Isenring EA, Bauer JD, Capra S. Nutrition     II +      RCT, Australia                 Randomised to receive either:            NI group had significantly higher protein (p<0.001) and     Noted study population mix
support using the American Dietetic                                                    Grp 1 (n=29) = intensive                 energy (p=0.029) intakes in the study.                      of both H&N and GI patients.
Association medical nutrition therapy                   N=60                           individualised nutrition counselling
                                                                                       by a Dietitian using a standard          Mean energy daily intakes were significantly higher in:
protocol for radiation oncology patients
                                                        All outpatients                protocol and oral supplements if         NI group (p=0.022)
improves dietary intake compared to                     commencing at least 20#        required or                              NI group had mean intake of 28-31kcal/kg/day
standard practice. J Am Diet Assoc                      RT to GI or H&N area at a      Grp 2 (n=31) = the usual practice of     UC group had mean intake of 25-29kcal/kg/day
2007;107:404-412.                                       private Australian             the centre (general advice and
                                                        radiation oncology facility    nutrition booklet).                      Mean protein daily intakes were significantly higher in:
                                                        during a 12-month period                                                NI group (p=0.001)
                                                        were eligible for inclusion.   Outcomes: Dietary intake (energy,        NI group had mean intake of 1.1-1.3gkg/day
                                                                                       protein, fibre)                          UC group had mean intake of 1.0-1.1g/kg/day

                                                                                       Timepoints: Baseline and 4, 8 and        Fibre intakes were not significantly different but had a
                                                                                       12 weeks after RT                        trend to higher intakes in the NI group.

Jager-Wittenaar H, Dijkstra PU, Vissink A,    IV Ø      Cross sectional, The           Patients classified into 3 groups:       Prevalence of post treatment malnutrition was 16%.          Low participation rate of
van der Laan BFAM, van Oort RP,                         Netherlands                     1. 0-3 months post treatment                                                                        66%.
Roodenburg JLN. Malnutrition and quality                                                2. 3-12 months post treatment           Univariate analysis: Malnourished patients scored worse
                                                        N=115                           3. >12 -36 months post treatment        on physical functioning and fatigue.
of life in patients treated for oral or
oropharyngeal cancer. Head & Neck                       Patients with oral or          Outcomes:                                Multivariate analysis: Malnutrition significantly related
2010;33:490-6.                                          oropharyngeal cancer who       Nutritional status (wt loss), QOL        to physical functioning.
                                                        have completed treatment.
Jager-Wittenaar H, Dijkstra PU, Vissink A,    IV +      Case series, The               Nutritional status (wt, lean mass, fat   During RT, body wt and lean mass significantly declined     Low participation rate –
et al. Changes in nutritional status and                Netherlands                    mass) and dietary intake assessed at 1   (wt mean loss 5.4kg, lean mass mean loss 2.8kg).            recruited 59% of those
dietary intake during and after head and                                               week pre RT, and 1 and 4 months                                                                      eligible.
                                                        N=29                           post RT.                                 Pts with sufficient intake (>35kcal/kg and >1.5g/kg) lost
neck cancer treatment. Head & Neck
                                                                                                                                less body weight/lean mass than those with insufficient     High drop out due to
2010;33:863-70.                                         Patients with head and         45% of pts required tube feeding. 12     intake.                                                     fatigue/death – 60% of which
                                                        neck cancer treated with       pts received prophylactic PEG, 1 pt                                                                  were malnourished.
                                                        RT (with or without            required NGT.                            Post treatment, only those with sufficient intake gained
                                                        surgery/chemotherapy).                                                  weight.

John DG, Fielder CP. The feeding              IV -      Case series, UK                Outcomes:                                Complications - Nil significant.                            Unlikely of clinical relevance
pharyngostomy: an alternative approach to                                              Complications                            Commonest complication was dislodgement (and needs          today.
enteral feeding. J Laryngol Otol                        N=33                           Duration                                 to be re-sited under general anaesthetic).
                                                                                                                                N=1 complain of discomfort
1991;105:451-3.
                                                        Any patient who                                                         N=1 slight infection at the stoma site.
                                                        underwent a feeding                                                     N=1 passed the last 3cm of his tube per rectum.
                                                        pharyngostomy between
                                                        1984-1989                                                               Duration - Average time was six and a half months.
                                                        N=20 (cancer upper air or                                               N=2 never used, N=1 still in use after 3 years.
                                                        food passage receiving                                                  N=4 who resumed normal swallowing had a persistent
                                                        RT) N=10 (4 had MND).                                                   cervical fistula after removal of the pharyngostomy tube.

Jyothirmayi R, Ramadas K, Varghese C,         II +      RCT, double blind, India       1.   Vitamin A - retinyl palmitate       Intervention group had 20% loco-regional recurrence         Finding maybe due to chance
Jacob R, Nair MK, Sankaranarayanan R.                                                       (200,000 IU/week)                   rate compared to 10% in placebo.                            given small numbers.
Efficacy of vitamin A in the prevention of              N= 106                         2.   Placebo (tapioca)
locoregional recurrence and second
                                                        H&N cancer pts                 Taken for 1 year post treatment.
primaries in head and neck cancer. European             completed surgery/RT
Journal of Cancer Part B: Oral Oncology                 with no evidence of            Follow up for 3 years.
1996;32:373-6.                                          disease.
Citation                                        Level &   Study Design & Sample         Intervention & Outcomes                  Results                                                   Comments
                                                Quality
Kandil E, Alabbas H, Jacob C, et al. A          IV -      Case Series                   Intervention:                            Mean age was 59.1 years (range 19-95).                    Only a 3 month follow up of
simple and safe minimally invasive                                                      Where indicated a laproscopic            3 female patients.                                        a small sample size of H&N
technique for laparoscopic gastrostomy.                   A retrospective chart audit   gastrostomy was used to insert a         Operative time was 29.8minutes (+\- 7.2).                 patients, with a non-
                                                          of patients who had a         feeding tube.                            No major intraoperative or postoperative complications    descriptive nature of the
Journal of the Society of Laparoendoscopic
                                                          laparoscopic gastrostomy                                               were observed.                                            H&N surgery that was
Surgeons 2010;14:62-5.                                    over a 9 month period.        Outcomes:                                Minor postoperative complications included, 3             originally undertaken.
                                                                                        Reason for insertion, age, sex,          superficial wounds, 2 dislodgement.
                                                          14 patients were audited:     indication for insertion and procedure   Feeding resumed within 24 hours from the operation.       PEG inserted gastrostomies
                                                          9 H&N cases                   specific and nonspecific                                                                           can commence feeding within
                                                          2 severe trauma               complications were recorded for a                                                                  4 hours, this paper reports
                                                          1 morbidly obese              mean follow up of 3 months.                                                                        feeding was undertaken
                                                          2 multiple upper                                                                                                                 within 24 hours post
                                                          abdominal surgery                                                                                                                insertion.

Kent MS, Awais O, Schuchert MJ, et al.          IV -      Case series, USA              Reason for placement                     n=18 for nutritional supplementation.                     Not specific to H&N cancer
Cervical pharyngostomy: an old technique                                                Duration                                 n=4 for drainage of mediastinal abscess                   and expansion of technique to
revisited. Ann Surg 2008;248:199-204.                     n=38                          Complications                            n=13 for decompression.                                   other areas of gastro surgery.
                                                                                                                                 n=3 other
                                                          All patients who
                                                          underwent placement of a                                               Complications:
                                                          pharyngostomy between                                                  Major – 0, Minor - 21
                                                          1995-2007.                                                             [Included cellulitis (n=1), oesophagitis (n=10), tube
                                                                                                                                 migration (n=9), aspiration pneumonia (n=1)].
                                                                                                                                 Duration - Mean duration of tube was 51 days (range= 1-
                                                                                                                                 279)
Kiremidjian-Schumacher L, Roy M,                II Ø      RCT, double blind, multi-     1.   Selenium 200ug/d for 8 weeks        In the selenium group:                                    8 week supplementation with
Glickman R, et al. Selenium and                           centre, USA                   2.   Placebo                                                                                       selenium enhanced immune
immunocompetence in patients with head                                                                                           Increased cytotoxic lymphocyte activity at 8 weeks        function, but does this
                                                          n=33                          Taken on day 1 of treatment and          compared to baseline P<0.005.                             translate to clinical
and neck cancer. Biol Trace Elem Res
                                                                                        continued for 8 weeks.                                                                             outcomes?
2000;73:97-111.                                           Untreated SCC H&N                                                      Lymphocyte proliferation was higher at 8 weeks            E.g. reduced
                                                                                        Immune function outcomes at              compared to baseline P<0.03.                              infections/morbidity.
                                                                                        baseline, 4,8,16 weeks
                                                                                        •     Serum selenium                     No significant differences after 16 weeks.
                                                                                        •     Immune function (lab
                                                                                              measures)

Koehler J, Buhl K. Percutaneous endoscopic      IV -      Case series, Germany          Clinical criteria for PEG insertion:     Weight gain post PEG insertion:                           Criteria for malnutrition not
gastrostomy for postoperative rehabilitation                                                 Malnutrition (n=6)                      3.1kg at 4 weeks, 6.4kg at 12 weeks                   defined.
after maxillofacial tumor surgery. Int J Oral             n=40                               Postoperative swallowing
                                                                                             disorders (n=22)                    Duration of tube use:                                     Criteria for PEG insertion not
Maxillofac Surg 1991;20:38-9.
                                                          Patients who had a PEG             Inoperable tumours or                    54 – 425 days                                        conclusive.
                                                          for postoperative                  recurrence (n=8)
                                                          rehabilitation after               Malnutrition following              Hospitalisation period:                                   Adhoc comparisons to NG,
                                                          maxillofacial tumor                radiotherapy (n = 4)                    50% shorter stay in PEG group compared to 22          PN and non PEG group for
                                                          surgery.                      Outcomes:                                    non PEG group who had curative surgery                LOS.
                                                                                             Weight at 4,12 weeks post PEG
                                                                                             Duration of use for PEG tube        PEG group who had previous experience of NGT:             Psychological factors not
                                                                                             PEG complications                       Aesthetic and psychological benefit                   discussed.
                                                                                             Aesthetics
                                                                                             Psychological aspects               Complications:
                                                                                             Cost (compared to parenteral            Peritonitis treated within 24 – 48 hrs post
                                                                                             nutrition)                              placement
                                                                                                                                     Entry site infection (n=8)
Citation                                       Level &     Study Design & Sample        Intervention & Outcomes                     Results                                                    Comments
                                               Quality
Kornguth DG, Garden AS, Zheng Y,               IV Ø        Case series, USA             75 pts (58%) had PEG’s:                     Factors associated with long term PEG feeding              Although not the primary
Dahlstrom KR, Wei Q, Sturgis EM.                                                        •     6.7% placed pre treatment,            • Older age, P<0.001                                       purpose of the study, this
Gastrostomy in oropharyngeal cancer                        N=130                        •     18.6% within 3/52                     • Use of CRT P<0.001                                       demonstrated statistically
                                                                                        •     Remainder before end of RT.           • High T (stage 1 or 2, vs. 3 or 4) P<0.001                significant higher PEG
patients with ERCC4 (XPF) germline
                                                           Newly diagnosed                                                          • and N (stage 0 vs. 1-3) P=0.021                          requirement in CRT.
variants. Int J Radiat Oncol Biol Phys                     oropharyngeal SCC            PEG insertion: typically this is when
2005;62:665-71.                                            undergoing definitive RT     the treating clinicians feel that pts are   There was no assoc b/t specific therapeutic combinations
                                                           or CRT.                      unable to meet their nutritional            of CRT (cisplat vs. taxanes vs. antiepidermal growth
                                                                                        requirements                                factor receptor antibody C225) and the need for PEG
                                                                                                                                    feeding.
                                                                                        Outcomes:
                                                                                        Patients requiring PEG feeding for          Presence of polymorphic ERCC4 2505 polymorphic C
                                                                                        >180 days.                                  allele assoc with less need for PEG placement OR 0.34.

Kubrak C, Olson K, Jha N, et al. Nutrition     IV Ø        Prospective cohort,          Assessed with PG-SGA before                 Anorexia, dysphagia, mouth sores were significant
impact symptoms: Key determinants of                       Canada                       treatment to measure symptoms.              predictors of reduced dietary intake and weight.
reduced dietary intake, weight loss, and
                                                           N=341                        Outcomes:                                   Pre tx symptoms accelerated time and probability of
reduced functional capacity of patients with
                                                                                        Dietary intake                              weight loss.
head and neck cancer before treatment.                     Patients with head and       Weight
Head & Neck 2010;32:290-300.                               neck cancer pre treatment.   Functional capacity                         BMI<18.5 related to overall survival.
                                                                                        Survival

Lango MN, Egleston B, Ende K, et al.           III-3 Ø     Retrospective cohort study   To investigate the effect of neck           Relative risk (following adjustment for covariates) of     Neck dissection may
Impact of neck dissection on long-term                     (database audit) (1993-      dissection on prolonged feeding tube        feeding tube dependence in the patients having             contribute to a long-term
feeding tube dependence in patients with       Prognosis   2004)                        dependence.                                 undergone neck dissection vs no neck dissection;           toxicity burden (chronic
                                                           Philadelphia, USA                                                        - at 18 months (RR 4.74, 95% CI 2.07-10.89. p = .001)      oropharyngeal dysphagia) in
head and neck cancer treated with primary
                                                                                        Only 67 of 180 were selected for            - at 24 months (RR 7.66, 95% CI 2.6-22.59, p = .001)       HNSCC patients treated with
radiation or chemoradiation. Head & Neck                   Neck dissection n=33         inclusion.                                                                                             primary radiation or
2010;32:341-7.                                             No neck dissection n=34                                                  Other independent predictors of feeding tube               chemoradiation. Survival
                                                                                        Two cohorts not equivalent because          dependence included pre treatment weight loss (p = .04)    benefits of post-radiation ND
                                                           Propensity score             decision on whether to perform ND           and advanced patient age (p = .03). The use of             not reported here.
                                                           adjustment.                  post treatment was based on clinical        chemotherapy had no measurable effect in this study.
                                                                                        judgement – therefore outcomes were                                                                    Identifies a nutritionally at-
                                                           Node-positive HNSCC          adjusted for baseline differences in                                                                   risk group needing long-term
                                                           (T1-4) oropharynx,           the groups.                                                                                            nutritional management.
                                                           larynx, and hypopharynx
                                                           treated with primary         Placement of a feeding tube during
                                                           radiation or                 the course of treatment as clinically
                                                           chemoradiation, with no      indicated. Pre treatment dysphagia
                                                           evidence of tumour           and weight loss, particularly in the
                                                           recurrence and follow-up     elderly, usually prompted
                                                           of at least 24 months.       prophylactic feeding tube placement
                                                                                        before treatment.
                                                           Presence of a feeding
                                                           tube at 12, 18, and 24       “Tube dependence” - The decision to
                                                           months.                      remove a feeding tube was most
                                                                                        commonly made by a single surgeon.
                                                                                        Feeding tubes were removed if
                                                                                        patients could maintain weight for at
                                                                                        least 6 weeks without using the
                                                                                        feeding tube.
Citation                                      Level &   Study Design & Sample        Intervention & Outcomes                 Results                                                    Comments
                                              Quality
Larsson M, Hedelin B, Johansson I, Athlin     IV Ø      Case series,                 Audit tool retrospectively applied to   Significant difference in patients who died or had
E. Eating problems and weight loss for                  Norway/Sweden                the medical record cards.               recurrence with eating problems and /or causes of eating
patients with head and neck cancer: a chart                                                                                  problems pretreatment, p=<0.15
                                                        N=50                         Data collection:
review from diagnosis until one year after
                                                                                          Eating problems                    Admission rates:
treatment. Cancer Nurs 2005;28:425-35.                  Primary HNC treated with          Causes and consequences            Pretreatment: n=6
                                                        external radiotherapy with        Undertaken interventions           3rd Week of RT: n=21 (43%) side effects or nutritional
                                                        or without surgery /                                                 problems
                                                        brachytherapy.               Time points:                            End of RT:
                                                                                          Diagnosis                               n=19 (38%) still hospitalised
                                                                                          Pre treatment                           n=24 (48%) admitted
                                                                                          Weekly during radiotherapy         1 month post treatment:
                                                                                          1 month post                            n=8 (17%) still hospitalised
                                                                                          6 month post                       6 months:
                                                                                          12 months post                          n=38 (95%) at home
                                                                                                                             12 months:
                                                                                     Outcomes:                                    n=31 (97%) at home
                                                                                          Eating problems
                                                                                          Pre Treatment                      Eating problems and causes during Pretreatment:
                                                                                          Occurrence and causes during            Total n=22 (44%)
                                                                                          treatment and follow up                 n=11 (22%): chewing and /or swallowing
                                                                                          Nutritional Status during               n=11 (22%): pain
                                                                                          treatment and follow up
                                                                                          Nutritional Interventions during   Eating problems and causes during treatment and
                                                                                          treatment and follow up            follow ups:
                                                                                                                             Percentage Incidence at stage of care:
                                                                                                                                   Pretreatment: n=50 with 44%
                                                                                                                                   3rd Week of RT: n=50 with 80%
                                                                                                                                   End of RT: n=50 with 100%
                                                                                                                                   1 month: n=47 with 94%
                                                                                                                                   6 months: n=40 with 85%
                                                                                                                                   12 months: n=32 with 88%
                                                                                                                             Number of patients who had their weights checked
                                                                                                                             during the study and percentage mean weight loss:
                                                                                                                                   End of RT: n=40 (80%) with mean = 6.8%;
                                                                                                                                   1 month post RT: n=22 (47%) with mean = 10.7%;
                                                                                                                                   6 months post RT: n=22 (55%) with mean =
                                                                                                                                   14.3%;
                                                                                                                                   12 months post RT: n=20 (62%) with mean =
                                                                                                                                   17.4%;
                                                                                                                             Longitudinal follow up of the n=20 patients (40%
                                                                                                                             with n=10 males and n=10 females) for % weight
                                                                                                                             loss:
                                                                                                                             Weight loss from start to 1 year post RT:
                                                                                                                                   n=16 continued to lose weight
                                                                                                                                   n=4 did not and stabilised at 5%, 10%, 3%,17%

                                                                                                                             Dietary Supplements:
                                                                                                                             Prescription for sip feeds:
                                                                                                                                  3 week RT: n=17 (34%)
                                                                                                                                  1 month: n=1 (2%)
                                                                                                                                  6 month: n=3 (8%)
                                                                                                                                  12 months: n=1 (3%)
Citation                                      Level &   Study Design & Sample      Intervention & Outcomes                 Results                                                    Comments
                                              Quality
                                                                                                                           Enteral Nutrition:
                                                                                                                           % patients requiring tube feeding:
                                                                                                                                3 weeks RT: n=13 (26%)
                                                                                                                                End of RT: n=21 (42%)
                                                                                                                                1 month: n=12 (26%)
                                                                                                                                6 months: n=4 (10%)
                                                                                                                                12 months: n=3 (9%)
                                                                                                                           Significant difference, p=0.24 with Tumour Sites:
                                                                                                                           Nasopharynx, Oropharynx, Hypopharynx

                                                                                                                           Significant difference, p=0.3 with n=22 for patients
                                                                                                                           documented with eating problems and /or cause of
                                                                                                                           eating problems:
                                                                                                                                Pre-treatment compared to those that had no
                                                                                                                                problems at pre treatment
                                                                                                                           Significant difference, p=0.45 Mann Whitney U test
                                                                                                                           with n=9/20 patients followed up longitudinally:
                                                                                                                                3rd week RT: Higher % weight loss compared to
                                                                                                                                those not followed up n=30

                                                                                                                           Parenteral Nutrition:
                                                                                                                           n=3 (6%): week 3 or 4 of RT
                                                                                                                           n=1 (4%): 1 month after RT

                                                                                                                           Patient Education & Support:
                                                                                                                           information about treatment and side effects:
                                                                                                                           Beginning of RT: N=35 (70%)
                                                                                                                           Later in treatment: N=14 (28%)

Larsson M, Hedelin B, Athlin E. A             IV Ø      Case series, qualitative   A qualitative study with a              The findings show that the nurse clinic was important to   No mention of the diagnosis
supportive nursing care clinic: Conceptions             study, Sweden              phenomenographic approach. They         these patients during the whole trajectory of care in      of swallowing difficulties by
of patients with head and neck cancer.                                             were asked two open ended broad         order to feel confident, safe and secure.                  a speech therapist, or if any
                                                        N=8                        questions ‘‘What problems and           It was obvious that it was conceived as most valuable      of the participants were on a
European Journal of Oncology Nursing
                                                                                   concerns have you experienced           during the periods before and after completion of the      textured modified diet/fluids.
2007;11:49-59.                                          Head and neck cancer       during this period?’’ and ’”What        treatment, when no other contact with the health care      Nursing clinic appeared to
                                                        patients with eating       significance has the nurse clinic had   system was regularly scheduled.                            take on role of a dietitian.
                                                        problems (chewing and/or   for you?’’
                                                        swallowing difficulties)
                                                        caused by the disease      First interview was carried out
                                                        and/or its treatment       between 1.5 to 3 months after
                                                                                   treatment was complete.
                                                        All participants had
                                                        received a service by
                                                        nursing staff as out-
                                                        patients at a clinic
                                                        designed to follow up on
                                                        patients well being and
                                                        nutrition before, during
                                                        and after completion of
                                                        radiotherapy.
Citation                                        Level &   Study Design & Sample       Intervention & Outcomes                   Results                                                     Comments
                                                Quality
Larsson M. Needing a hand to hold - lived       IV Ø      Case series, qualitative    Interview 6-12 weeks post Treatment       Care provided needs to:                                     Interpretation of data appears
experiences during the trajectory of care for             study, Sweden                                                         •    Focus on the patients’ multitude of needs rather       very subjective (towards
patients with head and neck cancer treated                                            Interviews conducted in open                   than on a single immediate need generated by           researcher beliefs).
                                                          N=9                         dialogue and started with broad                treatment and side effects.
with radiotherapy. Cancer nursing
                                                                                      question “please tell me about the        •    Provides consistency and continuity throughout the
2007;30:324-34.                                           Patients treated with RT    problems and concerns you have                 trajectory of care.
                                                          for HNC                     experienced during this period”.          •    Anticipate and assess patients’ problems and
                                                                                      covering trajectory of care from time          individual needs for information and support.
                                                                                      of diagnosis until the occasion for the   •    Before the end of the treatment, a discharge plan
                                                                                      interview.                                     that includes information about expected and
                                                                                                                                     unexpected side effects should be accomplished
                                                                                      Outcomes:                                      and availability must be ensured.
                                                                                      •   Eating problems due to illness
                                                                                          and Treatment                         The oncology nurses are in an ideal position to
                                                                                      •   Information and education             coordinate the care and make appropriate onward
                                                                                          received                              referrals to other specialists such as dietitians, dental
                                                                                      •   Contacts and continuity in the        hygienists, physicians and psychosocial counsellors
                                                                                          healthcare system                     when such expertise is required.
                                                                                      •   Social and emotional support

Lawenda B, Kelly K, Ladas E, et al. Should      IØ        Systematic review of        Searched MEDLINE for RCTs on              •     Data from limited number of RCTs have shown           Not specific to H&N cancer.
supplemental antioxidant administaration be               RCTs                        antioxidants with radiotherapy or               that high dose ant-oxidant supplementation during
avoided during chemotherpay and radiation                                             chemotherapy.                                   RT decreases local tumour control and shortens
                                                          N=9 (RT)                                                                    survival.
therapy? Journal of the National Cancer
                                                          N=16 (chemo)                                                          •     Limited data and theoretical understanding of
Institute 2008;100:773-783.
                                                                                                                                      mechanism suggests some antioxidants alone or in
                                                          Patients with cancer                                                        combination may enhance the effects of cytotoxic
                                                                                                                                      regimens and or decrease their toxicity.
                                                                                                                                •     Further research required.

Lawson JD, Gaultney J, Saba N, Grist W,         IV Ø      Case series, USA            PEG insertion pre treatment:              Median time of tube placement for all pts= 4.4 months       No information on oral
Davis L, Johnstone PAS. Percutaneous                                                  •    Radiological (n=75)                                                                              rehabilitation intervention
feeding tubes in patients with head and neck              N=102                       •    Endoscopically (n=18)                Median time of tube dependence for those who had            and nutritional status.
                                                                                      •    Outside facility (n=9)               eventual removal was 3.8 months (1.4-28.9)
cancer: rethinking prophylactic placement
                                                          Pts undergoing definitive   Tube removal after not using for 2/52     Tube-related toxicity:
for patients undergoing chemoradiation. Am                concurrent CRT for                                                    •    Requirement for tube replacement (11.8%). [tube
                                                                                      & pt maintaining wt.
J Otolaryngol 2009;30:244-9.                              HNCa: oral, salivary,                                                      occlusion (n=1) or dislodgement (n=11)].
                                                          paranasal sinuses & nasal   Median RT dose = 70 Gy                    •    Infection = 8.8%
                                                          cavity, pharynx, larynx,                                              •    Pain 5.9%
                                                          SCC unknown origin, who     Various CRT regimens: platinum/           •    Discharge 3.9%
                                                          had PEG placed pre-Rx.      taxane/ rituximab. Dose reduction &       •    Bleeding 1%
                                                                                      alterations at discretion of medical
                                                                                      staff.                                    Factors associated with tube retention:
                                                                                                                                •    African-American P=0.05
                                                                                      Outcome:                                  •    Older age
                                                                                      PEG dependence                            •    Advanced tumours
                                                                                                                                •    Taxane-containing CRT
                                                                                      Timing                                    Nodal status did not impact PEG reliance for group
                                                                                      f/up until death, tube removal or end
                                                                                      of study
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                Results                                                     Comments
                                               Quality
Lee H, Havrila C, Bravo V, et al. Effect of    III-3 Ø   Non-concurrent cohort        1.    std care n=40                    Wt loss in CRT pts:                                         Only examined wt loss
oral nutritional supplementation on weight               study, USA                   2.    NS intervention program          Std care 10.7% vs. NS 6.7% p=0.007                          during RT, not post.
loss and percutaneous endoscopic                                                            (n=39)
                                                         n=79                         Provision of complimentary Ensure      Wt loss in RT pts:                                          Provides evidence for
gastrostomy tube rates in patients treated
                                                                                      Plus to pts undergoing RT.             Std care 10.1% vs. NS 6.1% p-0.008                          multiple strategies for
with radiotherapy for oropharyngeal                      Oropharyngeal Ca pts                                                                                                            nutrition support even in pts
carcinoma. Support Care Cancer                           undergoing IMRT +            Intensive nutritional counselling      PEG pts wt loss:                                            with PEG.
2008;16:285-9.                                           chemo.                       provided by registered dietitian who   Std care 9.3% vs. 5.7% NS p=0.028
                                                                                      prescribed volume of supplement &
                                                         PEG insertion rates          reviewed weekly.                       Pts without PEG’s wt loss:
                                                         reported only for pts        All pts encouraged to consume          Std care 11.2% vs. 6.9% NS p=0.002
                                                         undergoing RT as many        supplements by dietitian, nursing
                                                         pts undergoing CRT have      staff & physicians.                    PEG insertion rate in RT alone pts reduced from 31% to
                                                         prophylactic PEG.            PEG insertion criterion was 10% wt     6% NS
                                                                                      loss during RT.
                                                                                      Outcome:                               Both groups (PEG and no PEG) experienced a 39%
                                                                                      % wt loss during RT                    relative reduction in wt loss.
                                                                                      wt taken weekly
Lee JH, Machtay M, Unger LD, et al.            III-2 Ø   Retrospective unmatched      Prophylactic gastrostomy (usually      Unplanned breaks from Rx (> 3 days from XRT) not            No randomization, groups not
Prophylactic gastrostomy tubes in patients               cohort undergoing            endoscopic) at the discretion of the   significantly different between groups. Trend in those      similar at baseline wrt
undergoing intensive irradiation for cancer              definitive or post-op XRT    treating physician, generally if       with higher Karnofsky score having fewer interruptions      performance status (p=0.006)
                                                         twice daily (56%, n=33)      expected ↑ toxic side effects 41%,     in peg group than no peg.                                   and pharyngeal primary
of the head and neck. Arch Otolaryngol
                                                         or CRT (paclitaxel n=10      n=36, vs. controls (n=52).                                                                         (p,0.001).
Head Neck Surg 1998;124:871-5.                           or Cisplatin n=19), Total                                           Unplanned hospitalizations for all causes (excluded 5 pts
                                                         n=88, majority= stage IV                                            who remained inpts) no significant difference between       Incomplete data on
                                                         (72%) Prophylactic                                                  groups (4 PEG pts under utilised their PEGs),               pretreatment wt loss.
                                                         gastrostomy in 41% vs. no                                           significantly fewer nutrition related admissions in PEG
                                                         PEG.                                                                group (p=0.04, 13% vs. 34%). 70% of hospitalizations        Selection criteria for PEG
                                                                                                                             overall were d/t malnutrition or dehydration.               placement depended on the
                                                                                                                                                                                         doctor.
                                                                                                                             Average wt loss =5.3kg overall, significantly more in the
                                                                                                                             control (7.0 + 4.6 vs. 3.1 + 2.5, p,0.001) Significant      Statistics presented.
                                                                                                                             difference in no. of patients with wt loss > 5% ( p=0.03
                                                                                                                             15 prophylactic vs. 37 controls).

                                                                                                                             Need for therapeutic PEG during Rx –those without
                                                                                                                             prophylactic PEG had significant more wt loss >4.5kg.

                                                                                                                             No significant difference on survival or local control.

Lees J. Nasogastric and percutaneous           III-2 -   Prospective cohort           Enteral feeding initiated in those     NG and PEG were equally effective in maintaining wt.        No randomization.
endoscopic gastrostomy feeding in head and               H&N ca patients receiving    unable to meet requirements or         NG fed patients (68%) tended to use pump delivery of        No statistics.
neck cancer patients receiving radiotherapy              radical and palliative XRT   maintain nutritional status on         1kcal/ml feed. Mean duration 21.3 days.                     QOL data not assessed with a
                                                         1993-5                       admission to the unit or during XRT.   PEG patients (32%) tended to have bolus 1.5kcal/ml          validated tool. QOL data on
treatment at a regional oncology unit: a two
                                                         n=100                                                               feeds. Mean duration 27.6 days.                             discomfort, blockage/
year study. Eur J Cancer Care (Engl)                                                  PEG placed if enteral feeding          Advantages with PEG feeds – greater mobility, cosmesis      displacement, mobility and
1997;6:45-9.                                                                          required >21days and XRT would not     and QOL (reduced pt discomfort, reduced risk of             cosmesis not reported or
                                                                                      be interrupted. n=32 (PEG), vs. n=     blockage or displacement, easier to administer bolus        compared and big
                                                                                      68 (n/g).                              feeds).                                                     generalizations made outside
                                                                                                                             NG tube not maintained in 7% (n=5).                         the scope of the paper.

                                                                                                                             Survival: 7% in each group died during admission. At 6
                                                                                                                             months, 66% NG pt had died, 78% PEG pt had died.
Citation                                        Level &   Study Design & Sample        Intervention & Outcomes                 Results                                                    Comments
                                                Quality
Lees J. Incidence of weight loss in head and    IV Ø      Case series, UK              Outcomes:                               Prior to RT:                                               A very basic paper that does
neck cancer patients on commencing                                                     Wt (kg), BMI                            57 (57%) had lost weight (95% of which unintentional);     not contribute significantly to
radiotherapy treatment at a regional                      N=100                        Baseline nutritional status (wt, BMI)   12 (12%) had gained weight prior to commencing Rx          body of evidence other than
                                                                                       on commencing RT compared with          (25% of which unintentional);                              H&N patients are at high risk
oncology centre. Eur J Cancer Care (Engl)
                                                          H&N cancer patients on       usual wt and BMI. Period of wt          31 (31%) were weight stable.                               of weight loss even on
1999;8:133-6.                                             commencing RT treatment      change, % wt change and reasons for     Mean reported wt loss -6.5kg (9.7%)                        presentation and symptoms
                                                          palliative or curative.      wt fluctuation were then determined.    Mean reported wt gain +7.4kg (7.4%)                        that commonly impact on p o
                                                                                                                                                                                          intake (both are probably
                                                                                                                               Incidence of causative factors of weight loss listed:      well-documented elsewhere).
                                                                                                                               Most common: xerostomia (59%); dentures (57%); sore        Cohort not homogeneous.
                                                                                                                               mouth (44%), difficulty swallowing (37%); difficulty       Nutritional status not
                                                                                                                               masticating (34%), taste changes (28%), constipation       measured.
                                                                                                                               28%).
Li B, Li D, Lau DH, et al. Clinical-            IV Ø      Case series, USA             Observational study. Nutrition          Median max wt loss= 12% (-4%-21%).                         Continuation of PEG feeding
dosimetric analysis of measures of                                                     intervention as per ADA MNT                                                                        based on physician judgment:
dysphagia including gastrostomy-tube                      N=39                         protocol. Those with >grade 2           Grade 3 or 4 mucositis: 50% after RT, 23% at 3/12, 5%      wt could not be maintained
                                                                                       dysphagia at 3/12 were referred for     at 6/12.                                                   on <2 cans of supplemental
dependence among head and neck cancer
                                                          Newly Dx SCC oral            Tran nasal endoscopy + FEES at                                                                     feeding/day or could not
patients treated definitively by intensity-               cavity, oropharynx, larynx   physician discretion.                   4/7 pts who had FEES had mod/severe dysphagia.             tolerate solid food without
modulated radiotherapy with concurrent                    or hypopharynx treated                                                                                                          complaints of dysphagia.
chemotherapy. Radiat Oncol 2009;4:52.                     with IMRT & CRT who          Outcomes:                               GT dependence: 87% at 3/12, 4% at 6/12
                                                          received prior               •   Duration of PEG feeding:            •   Smoking significant assoc with prolonged GT
                                                          prophylactic PEG.                beginning of Rx to removal.             dependence.
                                                                                       •   Lowest wt during follow-up          •   No significant assoc with age, gender, Hx of EtOH
                                                                                           period                                  abuse, KPS, tumour site, stage, N stage, CRT
                                                                                       •   Pt reported dysphagia                   regimen.
                                                                                       •   Mucositis and xerostomia            •   There were strong dosimetric-clinical correlations
                                                                                                                                   for cricoid pharyngeal inlet and inferior pharyngeal
                                                                                       Follow up:                                  constrictor: V65 of inferior pharyngeal constrictor,
                                                                                       2-3/52 post Rx , then q 3/12                V 60 of inferior pharyngeal constrictor: mean dose
                                                                                       (median 15.6 months).                       to inferior pharyngeal constrictor:, and max dose to
                                                                                                                                   cricoid pharyngeal inlet were significant assoc with
                                                                                                                                   prolonged PEG dependence.

Lin HS, Ibrahim HZ, Kheng JW, Fee WE,           IV Ø      Case series, USA             Ponsky’s ‘pull’ PEG insertion –         •    Overall complication rate = 11.7% (58.3%
Terris DJ. Percutaneous endoscopic                                                     minimum 3 month post placement               occurred <2 wks after surgery)
gastrostomy: strategies for prevention and                N=103                        f/up                                    •    No mortality
management of complications.                                                                                                   •    Minor complication rate = 11/103 (10.7%)
                                                          Review of all PEG            Outcomes:                               •    Major complication rate = 1/103 (1%)
Laryngoscope 2001;111:1847-52.                            insertions at the centre -   •   No complications
                                                          84/103 (84%) patients        •   Minor complications
                                                          were H&N cancer              •   Major complications
                                                          patients.                    •   Mortality

Lin L-C, Que J, Lin L-K, Lin F-C. Zinc          II +      RCT, double blind,           1.   Zinc 25mg tds                      Placebo group developed
supplementation to improve mucositis and                  Taiwan                       2.   Placebo (soybean oil)              •    Grade II mucositis earlier P=0.017
dermatitis in patients after radiotherapy for                                                                                  •    Grade II dermatitis earlier P=0.014
                                                          N=97                         Taken daily during RT treatment with    •    Grade III mucositis earlier P=0.0003
head-and-neck cancers: a double-blind,
                                                                                       median f/up 22.3months.                 •    Grade III dermatitis earlier P=0.0092
randomized study. Int J Radiat Oncol Biol                 H&N cancer treated with
Phys 2006;65:745-50.                                      radiotherapy (+ chemo).      Outcomes:                               Zinc group had
                                                                                       Mucositis & dermatitis grade            •    milder mucositis and dermatitis P=0.003
                                                                                       Weight                                  No difference on wt
Citation                                       Level &   Study Design & Sample          Intervention & Outcomes                  Results                                                    Comments
                                               Quality
Lin L-C, Que J, Lin K-L, Leung HW-C, Lu        II +      RCT, double blind,             1.   Zinc 25mg tds                       No difference between groups for overall survival,
C-L, Chang C-H. Effects of zinc                          Taiwan                         2.   Placebo (soybean oil)               disease free survival or mets.
supplementation on clinical outcomes in
                                                         N=97                           Taken daily during RT treatment with     Trend to increased local free survival in zinc group
patients receiving radiotherapy for head and
                                                                                        median f/up 22.3months.                  P=0.095.
neck cancers: a double-blinded randomized                H&N cancer treated with
study. Int J Radiat Oncol Biol Phys                      radiotherapy (+ chemo).        Outcomes:                                Stage III-IV pts having CRT in zinc group had increased
2008;70:368-73.                                                                         3yr survival                             local free survival P=0.003.

Lin Y-S, Lin L-C, Lin S-W. Effects of zinc     II +      RCT, double blind,             1.   Zinc 25mg tds                       Zinc group had significantly higher:
supplementation on the survival of patients              Taiwan                         2.   Placebo (soybean oil)               •    Overall survival (P=0.044)
who received concomitant chemotherapy                                                                                            •    Local free survival (P=0.007)
                                                         N=34                           Taken daily during RT treatment with     •    Disease free survival (P=0.033)
and radiotherapy for advanced
                                                                                        median f/up 22.3months
nasopharyngeal carcinoma: follow-up of a                 (sub group of larger trial –                                            No effect of mets free survival.
double-blind randomized study with                       stage III and IV               Outcomes:
subgroup analysis. Laryngoscope                          nasopharynx ca treated by      5yr survival
2009;119:1348-52.                                        CRT only)

Lin Y-S, Lin L-C, Lin S-W, Chang C-P.          II Ø      RCT (double-blind)             Intervention:                            Placebo vs. Zinc:                                          Dose of RT significantly
Discrepancy of the effects of zinc                       Taiwan                                                                                                                             greater for pts with NPC than
supplementation on the prevention of                                                    Control Group (n=42); NPC (19), OC       Grade 2 mucositis (P=0.009) and Grade 3 mucositis          OC.
                                                         N=100                          (23)                                     (P=0.001) appeared sooner in the placebo group than the
radiotherapy-induced mucositis between
                                                         HNSCC undergoing CRT           Placebo capsules (soybean oil).          experimental group.
patients with nasopharyngeal carcinoma and               (3D conformal RT not
those with oral cancers: subgroup analysis               IMRT)                          Intervention Group (n=44); NPC           Both patient groups exhibited a large fluctuation with a
of a double-blind, randomized study. Nutr                                               (21), OC (23)                            wide range of SD in serum Zn levels.
Cancer 2010;62:682-91.                                   (subgroup analysis of 40       25mg Pro Z x 3 capsules/d for 2/12.
                                                         NPC, 43 OC)                                                             Duration of severe mucositis between placebo and
                                                                                        No significant differences in baseline   control groups (3.12 vs. 5.14 wk; P=0.001) for pts with
                                                                                        demographics, however, proportion        OC but not NPC.
                                                                                        of pts with OC reported habit of areca
                                                                                        quid chewing significantly greater       Subgroup analysis:
                                                                                        than pts with NPC (32, 69.6% vs. 2,      OC: Grade 2 mucositis (P<0.001) and Grade 3 mucositis
                                                                                        5%, p<0.001).                            (P<0.001) appeared sooner in the placebo group than the
                                                                                                                                 experimental group, however for pts with NPC there was
                                                                                                                                 no significant difference.

                                                                                                                                 Conclusion:
                                                                                                                                 Zn supplementation with Pro Z is effective in improving
                                                                                                                                 mucositis in pts with OC under either definitive or
                                                                                                                                 adjuvant RT, however, benefits were not found to extend
                                                                                                                                 to pts with NPC.
Citation                                    Level &   Study Design & Sample      Intervention & Outcomes              Results                                            Comments
                                            Quality
Linn BS, Robinson DS. The possible impact   III-3 Ø   Comparative Study          Prior DRGs; n = 59After DRGs; n =    Nutritional status                                 Difference in health systems
of DRGs on nutritional status of patients             without concurrent         61.                                      Nutrition score at admission: (NS)             noted – however overall
having surgery for cancer of the head and             controls, USA                                                   Pre DRG: 11.0 Post DRG; 11.3                       impact of reducing pre-op
                                                                                 Outcomes:                                Malnourished patients at admission:            admission time (by
neck. JAMA 1988;260:514-8.
                                                      N=120                      •   Nutritional status (using the    Pre DRG: 49% Post DRG; 44%                         introduction of DRG and
                                                                                     Protein Energy Malnutrition          Nutrition score at surgery:                    prospective payment system),
                                                      Men admitted for massive       Scale (PEMS) at admission and    Pre DRG: 8.1 Post DRG; 10.3                        is less nutrition intervention
                                                      resections of HNC.             time of surgery (1-2 days pre        Malnourished patients at surgery: P<0.02       pre-op. Resulting in higher
                                                                                     op)                              Pre DRG: 20% Post DRG; 33%                         rates of malnutrition which is
                                                                                 •   Post operative complications –       Malnourished pts receiving treatment:          linked to increased
                                                                                     up to 30 days post op            Pre DRG: 14/29 (48%) for mean 10 days              complications and LOS post
                                                                                 •   LOS                              Post DRG: 7/27 (26%) for mean 3 days               op.
                                                                                 •   Readmission rates within 90
                                                                                     days                             LOS pre op                                         Provides support for pre op
                                                                                                                      Well nourished: P<0.05                             nutrition intervention even as
                                                                                                                      Pre DRG: 16 days Post DRG: 4 days                  outpatient.
                                                                                                                      Malnourished: P<0.05
                                                                                                                      Pre DRG; 22 days Post DRG: 6 days

                                                                                                                      LOS post op
                                                                                                                      LOS malnourished versus well nourished patients
                                                                                                                      differed greatly (p<0.001)
                                                                                                                      Well nourished:
                                                                                                                      Pre DRG: 11 days Post DRG: 10 days
                                                                                                                      Malnourished: (NS)
                                                                                                                      Pre DRG; 23 days Post DRG: 17 days

                                                                                                                      Readmissions
                                                                                                                      Significantly more readmissions for malnourished
                                                                                                                      patients p < 0.05
                                                                                                                      Well nourished:
                                                                                                                      Pre DRG: n=10 (33%) Post DRG: n=7 (22%)
                                                                                                                      Malnourished:
                                                                                                                      Pre DRG; n=14 (50%) Post DRG: n=17 (60%)

                                                                                                                      Complication scores
                                                                                                                      Well nourished: Pre DRG: 3 Post DRG: 3
                                                                                                                      Malnourished: Pre DRG; 5 Post DRG: 12

                                                                                                                      Infections malnourish
                                                                                                                      Pre DRG:19% Post DRG:32%
Citation                                    Level &   Study Design & Sample      Intervention & Outcomes             Results                                                   Comments
                                            Quality
Linn BS, Robinson DS, Klimas NG. Effects    III-2 Ø   Comparative study with     Baseline measure                    Surgery
of age and nutritional status on surgical             concurrent controls, USA   • Nutritional Status (2 days pre-   Older group – less likely to have surgery with higher
outcomes in head and neck cancer. Ann                                                 op)                            stage of cancer compared to younger patients. p < 0.01.
                                                      N=120                          o Protein Energy Malnutrition   Patients excluded from surgery due to unresectable
Surg 1988;207:267-73.
                                                                                          Scale (PEMS)               tumours - 22% of the old, 33% of the young.
                                                      Age 60+ : n=65                 o score 8+ malnourished
                                                      Age <60 : n=55                 o score <8 well nourished       Malnutrition
                                                                                                                     Degree of malnutrition did not differ by age groups
                                                      Men admitted for           Outcomes                            (NS). 58% of old 55% of young.
                                                      treatment for head and     • Immune Status                     Malnourished old had higher PEMS scores than any
                                                      neck SCC to the surgical   • Complications – up to 30 days     other group. P<0.05. Old malnourished became more
                                                      wards.                         post op                         malnourished, young malnourished stabilized.
                                                                                 • LOS post op
                                                                                 • Readmission rates – within 90     Symptoms
                                                                                     days of d/c                     Young patients had more symptoms than the old in:
                                                                                                                         • Trouble swallowing p< 0.05
                                                                                                                         • Weight loss p<0.001
                                                                                                                     Malnourished patients reported greater symptoms in
                                                                                                                     both age groups:
                                                                                                                         • Nausea p< 0.05
                                                                                                                         • Greater hoarseness p < 0.01
                                                                                                                         • Trouble swallowing p <0.01
                                                                                                                         • Greater weight loss p < 0.05

                                                                                                                     Immune Status
                                                                                                                     Malnourished patients had lower immune function as
                                                                                                                     reflected by lymphocyte responses.

                                                                                                                     Surgical Outcomes
                                                                                                                     LOS were significantly more for malnourished than well
                                                                                                                     nourished patients p < 0.05.

                                                                                                                     Complications
                                                                                                                     Greater in malnourished patients than well nourished
                                                                                                                     patients. p < 0.05.
                                                                                                                     If old and malnourished more likely to have
                                                                                                                     complications and die within 1 year than other groups.
                                                                                                                     Greater degree of malnutrition was correlated with
                                                                                                                     postoperative complications and death P<0.01.

                                                                                                                     Preoperative Nutritional Support
                                                                                                                     Old malnourished – 20% had nutrition support pre-op
                                                                                                                     Young malnourished – 60% had EN or PN pre-op
Citation                                     Level &   Study Design & Sample       Intervention & Outcomes           Results                                                    Comments
                                             Quality
Logemann JA, Pauloski BR, Rademaker          IV Ø      Case series, multicentre,   Xerostomia and swallow function   Saliva Production:                                         No data with regard to
AW, et al. Xerostomia: 12-month changes in             USA                         post CRT.                         Pre treatment - 3 months: significant decline, <0.05, 6    nutritional status of patients
saliva production and its relationship to                                                                            months - 12 months: significant decline compared to pre    for the duration of the study
                                                       N=30                        Outcomes:                         treatment p=<0.0001.                                       or intensity and frequency of
perception and performance of swallow
                                                                                       Patients perception                                                                      dietetic intervention.
function, oral intake, and diet after                  HNC patients diagnosed          Saliva production             Nature of oral intake:                                     Outcomes of tube feeding
chemoradiation. Head Neck 2003;25:432-7.               with advanced disease in        Oropharynx swallow function   <50%:                                                      patients not discussed.
                                                       the oropharynx treated          Nature of oral intake         Pre treatment - 3 months: significant increase <0.05
                                                       with chemoradiotherapy.                                       12 months: significant declined compared to 3 months
                                                                                   Time points:                      p=0.01.
                                                                                       Before treatment              Not eat all food consistencies:
                                                                                       3 months after treatment      Pre treatment to 3 months and 6 months post treatment:
                                                                                       6 months after treatment      significantly increased.
                                                                                       12 months after treatment     Tube feeding:
                                                                                                                     N=10 with tube in situ at one or more point in follow up
                                                                                                                     Pre treatment: n=3 (2 were taking full oral nutrition
                                                                                                                     100%)
                                                                                                                     1m: n=11 (n=1,100% oral intake), 3m: n=10
                                                                                                                     6m: n=4 (n=1,100% oral intake), 12m:n=2

                                                                                                                     Frequency of eating and swallowing relate
                                                                                                                     complaints significantly increased at 3m, 6m and 12
                                                                                                                     month compared to pre treatment:
                                                                                                                        Dry mouth: (pre=34%, 3-12m=90-100%), p=<
                                                                                                                        0.0001
                                                                                                                        Need water to assist: (pre=24%, 3-12m=83-90%),
                                                                                                                        p=< 0.0001
                                                                                                                        Changes in taste: (pre=10%, 3-12m=60-89%,
                                                                                                                        improvement at 12m), p=< 0.0001
                                                                                                                        Food sticking in mouth: (pre=21%, 3-12m=67-69%),
                                                                                                                        p=< 0.0001
                                                                                                                        Food sticking in throat; (pre=17%, 3-12m=47-69%,
                                                                                                                        worse at 6m), p=< 0.0001
                                                                                                                        Coughing: (pre=38%, 3-12m=62-67%, worse at 3m),
                                                                                                                        p=< 0.0002
                                                                                                                        Food will not go down: (pre=21%, 3-12m=55-60%,
                                                                                                                        worse at 3m), p=< 0.0001
                                                                                                                        Choking: (pre=24%, 3-12m=34-53%), p=0.07
                                                                                                                        Food / liquid comes up: (pre=14%, 3-12m=7-27%,
                                                                                                                        worse at 3+12m), p=0.14
                                                                                                                        Heartburn: (pre=48%, 3-12m=23-37%, improved
                                                                                                                        with time), p=0.02
                                                                                                                        Night Cough / gag: (pre=48%, 3-12m=33-
                                                                                                                        50%,improved with time), p=0.48
                                                                                                                        Swallowing problems: (pre=52%, 3-12m=57-70%),
                                                                                                                        p=0.24

                                                                                                                     Comparison of Saliva Weight in patients with and
                                                                                                                     without swallow complaints:
                                                                                                                     Patients with swallowing complaints had lower saliva
                                                                                                                     wt.
Citation                                      Level &   Study Design & Sample        Intervention & Outcomes                Results                                                       Comments
                                              Quality
Lorentzen T, Nolsoe CP, Adamsen S.            IV Ø      Case series, Denmark         PRG with min 30 days f/up post         Overall mortality 19%
Percutaneous radiologic gastrostomy with a                                           placement.                             Mortality from procedure itself 1.9%
simplified gastropexy technique under                   N=154                                                               Major complications 3.2%
                                                                                     Outcomes:                              Minor complications 14%
ultrasonographic and fluoroscopic guidance:
                                                        Patients who had insertion       Overall mortality                  Simple tube displacement (no complications) 8%
experience in 154 patients. Acta Radiol                 of PRG - 113 pts (73%)           Mortality from procedure itself
2007;48:13-9.                                           neurological disease, 23         Major/minor complications          High mortality rate, authors note that they changed their
                                                        (15%) H&N ca pts, 18             Simple tube displacement (no       PRG technique to help reduce this (i.e. suture T-fastener
                                                        (12%) other disease.             complications)                     to skin for 10 days, balloon inflated with contrast instead
                                                                                                                            of saline).


Luetzow AM, Chaffoo RA, Young H.              IV Ø      Case series, USA             PG insertion (n=18 Ponsky’s PEG,           Overall success rate = 96% (23/24 successful
Percutaneous gastrostomy: the Stanford                                               n=6 had PG via fluoroscopic                placements)
experience. Laryngoscope 1988;98:1035-9.                N=24                         guidance) with f/up monthly during         Mortality 0% (although 4 pts died within 30 days of
                                                                                     first year, bi-monthly in 2nd year.        PG insertion, other cause)
                                                        Pts having Percutaneous                                                 Morbidity 43%: minor complication rate = 7, major
                                                        Gastrostomy (PG)             Outcomes:                                  complication rate = 2
                                                        insertion with H&N               PG operation time                      Ave operation time = 22 mins
                                                        cancer.                          Anaesthesia                            Tubes in place average 19 wks
                                                                                         Peri-operative complications           Cost of PG approx 1/3 of cost of open gastrostomy
                                                                                         Cost                                   (including anaesthesia, theatre etc)
                                                                                                                                80% required only local anaesthetic, 20% had
                                                                                                                                general anaesthetic (with other scheduled H&N
                                                                                                                                procedure)


Luman W, Kwek KR, Loi KL, Chiam MA,           IV Ø      Case series, Singapore       Ponsky’s ‘pull’ PEG insertion          Minor complications:                                          Limited data on return to oral
Cheung WK, Ng HS. Percutaneous                                                                                              Superficial wound infection 22.4%, granuloma 31%,             intake.
endoscopic gastrostomy--indications and                 N=181                        Outcomes:                              also noted abscess 2.8%, ileus (1 patient) and buried
                                                                                         Immediate complication rates       bumper/necrosis (1 patient).                                  Unclear period of f/up post
outcome of our experience at the Singapore
                                                        All PEG insertions (CVD          i.e. minor/major                                                                                 procedure.
General Hospital. Singapore Med J                       60.4%, cancer 24.7%,             Long-term outcomes i.e.            Major complications: Peritonitis 2.3%, GI bleed 0.6%.
2001;42:460-5.                                          neuro 10.9%, head injury         morbidity, return to oral intake
                                                        4%).                                                                Long-term outcomes:
                                                                                                                            Morbidity: 1 month 11.5% (16 pts died within 30 days
                                                                                                                            of insertion) – only 1 attributable to PEG insertion, 6
                                                                                                                            months 28.2%.
Citation                                       Level &   Study Design & Sample         Intervention & Outcomes                    Results                                                       Comments
                                               Quality
Machtay M, Moughan J, Trotti A, et al.         III-2 Ø   Retrospective meta            Univariate and multivariable logistic      Incidence of late toxicity in study participants:                Presence of feeding tube
Factors associated with severe late toxicity             analysis of 3 prospective     regression models used to identify             99 / 230 patients at 43% (no toxicity in 131/230             dependence used as a
after concurrent chemoradiation for locally              Radiation Therapy             associations of pre and post treatment         patients)                                                    measure of pre treatment
                                                         Oncology Group (RTOG)         related factors for late toxicity with a                                                                    laryngopharyngeal
advanced head and neck cancer: an RTOG
                                                         trials.                       level set at P<.05.                        Authors comment in order to demonstrate effects of late          dysfunction for exclusion
analysis. J Clin Oncol 2008;26:3582-9.                                                                                            studies this should include all participants (n=479) and         criteria could be a flaw
                                                         N=230                                                                    therefore crude reporting rate would be 21% not 43%.             of this study.

                                                         Non metastatic T3/4                                                      Pre treatment characteristics in study participants              >5% weight loss in 6
                                                         SCCHNC treated with                                                      significantly associated with late toxicity as a continuous      months pre treatment not
                                                         CCRT with defined severe                                                 variable:                                                        associated with late
                                                         late toxicity - one or more                                                  Age, median range =70, (p=0.038) in patients >70             toxicity. % weight loss
                                                         of the following 180 days                                                    T3/T4 (p=0.039)                                              from day 1 of RT starting
                                                         after starting RT:                                                           Tumour site, larynx and hypopharynx (p=0.0131)               to 180 days following
                                                              Chronic grade 3-4                                                                                                                    should have also been
                                                              pharyngeal / laryngeal                                              Treatment characteristics in study participants                  evaluated as a clinical
                                                              toxicity                                                            significantly associated with late toxicity on Unitarian         factor associated with
                                                              Requirement for a                                                   analysis:                                                        late toxicity.
                                                              feeding tube >/ 2 year                                                  BED (p=<0.0001) with a negative association of
                                                              after registration                                                      BED and severe late toxicity (i.e. lower RT therapy          No mention of the
                                                              Potential treatment                                                     dose associated with higher risk)                            patients baseline
                                                              related death (e.g.                                                                                                                  nutritional status.
                                                              pneumonia or                                                        Characteristics in study participants significantly
                                                              unknown cause)                                                      associated with late toxicity on multivariable logistical
                                                              within 3 years                                                      regression model analysis:
                                                                                                                                      Age (p=0.001)
                                                                                                                                      T3/4 (p=0.0036)
                                                                                                                                      Tumour site, larynx and hypopharynx (p=0.041)
                                                                                                                                      Neck dissection after RT (p=0.18)

                                                                                                                                  Time to severe late toxicity: subgroup analysis based on
                                                                                                                                  patient / treatment characteristics:
                                                                                                                                      T stage: Advanced T stage (p=0.0311)
                                                                                                                                      Primary tumour site: larynx / hypopharynx cancer
                                                                                                                                      associated with non significant higher likelihood
                                                                                                                                      (p=0.076)
                                                                                                                                      Neck dissection: statistically non significant
                                                                                                                                      likelihood (p=0.09)
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                   Results                                                      Comments
                                               Quality
Macqueen CE, Frost G. Visual analog            IV Ø      Single arm study.            Use of visual analogue scale (to          Laryngeal cancer pts: All managed on oral diet with
scales: a screening tool for assessing                                                assess appetite, taste, dysphagia for     40% taking 1 sip feed/day at end of RT, none required
nutritional need in head and neck                        20 newly diagnosed pts       solids and liquids i.e. items scored in   sip feeds 2/12 post.
                                                         with SCC larynx ( n=10)      the PG-SGA) at commencement of            Pharyngeal cancer: All required nutrition intervention
radiotherapy patients. J Hum Nutr Diet
                                                         or pharyngeal ( n=10)        RT, half way, end of RT, 2/12.            i.e.: PEG (n=2), N/g ( n=1) or sip feeds ( n=7, of whom
1998;11:115-24.                                          undergoing RT.                                                         2 took as sole source of nutrition), 50% ( n=5) still
                                                                                                                                heavily reliant on nutrition support 2/12 post.
                                                                                                                                No significant wt loss during RT for laryngeal cancer.
                                                                                                                                Significant wt loss in pharyngeal group (av=3kg,
                                                                                                                                P=0.009) despite vigorous nutritional support (due to
                                                                                                                                refusal of tube feeding/poor tolerance of oral supps/
                                                                                                                                medical instability). Validated tool to assess nutritional
                                                                                                                                risk in head and neck ca pts on RT.
Magne N, Marcy PY, Foa C, et al.               IV Ø      90 consecutive patients,     Peg (n=50) vs. N/g (n=40) outcomes        No major complications of PEG or N/g. Longest                   Groups similar at
Comparison between nasogastric tube                      Stage IV, undergoing         from intakes of 8400kJ + clear fluids/    duration of use=605 days (PEG), 89 days (N/g).                  baseline.
feeding and percutaneous fluoroscopic                    twice daily radiotherapy +   additional oral diet.                                                                                     Equal treatment
                                                         chemotherapy.                                                          Minor complications 17 episodes in 40 patients PEG, 61          regimens.
gastrostomy in advanced head and neck
                                                                                                                                episodes in 40 pts N/g.                                         Data obtained for
cancer patients. Eur Arch Otorhinolaryngol                                                                                                                                                      medical charts
2001;258:89-92.                                                                                                                 21 cases of aspiration pneumonia vs. 6 (PEG).                   retrospectively.
                                                                                                                                Mechanical failure in 32/40 NGT vs. 5/50 PEG pts.               No statistics on
                                                                                                                                                                                                difference in rates of
                                                                                                                                Mean wt ↑=2.5kg PEG vs. 0.7 N/g, no statistical                 aspiration pneumonia or
                                                                                                                                significant difference in BMI at weeks 1, 3 or 6.               mechanical failure.
                                                                                                                                                                                                Identifies the need for a
                                                                                                                                                                                                RCT to determine effect
                                                                                                                                                                                                on survival.
                                                                                                                                                                                                QOL in 33 long term
                                                                                                                                                                                                survivors: not adequately
                                                                                                                                                                                                presented/discussed.
                                                                                                                                                                                                Did not account for oral
                                                                                                                                                                                                intake.
Mahdavi R. Consequences of radiotherapy        IV Ø      Prospective case series,     n=11 oesophagus                           Malnutrition Overall: Incidence of malnutrition
on nutritional status, dietary intake, serum             Iran                         n=22 head and neck                        (mod+severe) increased from 62.3% at onset of RT to
zinc and copper levels in patients with                                               n=12 colorectal                           73.3% at end of RT, p=0.01.
                                                         N=45                                                                   Head and neck: Malnutrition increased from 59.1% to
gastrointestinal tract and head and neck
                                                                                      PGSGA and bloods at start and end         77.3% (p=0.007)
cancer. Saudi medical journal 2007;28:435-               Patients with                of RT, wt and intake taken weekly         Body weight changes Head and neck:
40.                                                      gastrointestinal tract and   during RT.                                     Mean BW significantly decreased during RT
                                                         head and neck cancer who                                                    (p=0.02)
                                                         received radiotherapy.       Outcomes:                                 Energy and protein intakes Head and neck:
                                                                                          Nutritional status                         Decreased significantly during radiotherapy
                                                                                          Changes in energy/protein                  (p=0.005 and p=0.01)
                                                                                          intakes                               Mean serum zinc Overall:
                                                                                          Changes in body weight                     Significantly lower than before RT (p=0.002)
                                                                                          Changes in serum zinc, copper         Head and neck:
                                                                                          and albumin levels                         Decreased significantly after RT (p=0.03)
                                                                                                                                Mean serum copper Overall:
                                                                                                                                     Decreased significantly after radiotherapy
                                                                                                                                     (p=0.003)
                                                                                                                                     Decreased insignificantly in all groups after RT
                                                                                                                                Mean serum albumin
                                                                                                                                     Decreased significantly in all groups (<0.05)
                                                                                                                                     compared with pre-RT levels
Citation                                      Level &   Study Design & Sample         Intervention & Outcomes                Results                                                    Comments
                                              Quality
Mandal A, Steel A, Davidson AR, Ashby C.      IV Ø      Case series, UK               PEG insertion                          •    Success rate – 92% (33 pts)                           Data collection of post-
Day-case percutaneous endoscopic                                                                                             •    Complication rates – within 1 month of PEG =          operative outcomes was
gastrostomy: A viable proposition? Postgrad             N=36                          Outcomes:                                   21% (7 pts, 4 required hospital stays, no surgical    unclear.
Med J 2000;76:157-9.                                                                  • Success rate                              intervention)
                                                        All patients that had PEG     • Complication rates – within 1        •    Mortality – 3% (1 pt from Cx, 5 total deaths due to
                                                        insertion as a day case (15       month of PEG                            primary disease within 1 month of PEG, no
                                                        pts with H&N Ca, 5            • Mortality                                 attributable)
                                                        stroke, 3 motor neurone       • Long-term outcomes – tube            •    Long-term outcomes – tube removal, PEG inset 3-
                                                        disease, 3 MS, 2 AIDS, 5          removal                                 30 months; 18 (55%) had tube for 1 yr, 2 (6%) for
                                                        other).                                                                   2.5 yrs


Mangar S, Slevin N, Mais K, Sykes A.          IV Ø      Retrospective                 Studied pats requiring EN (n=50):      Common factors increasing risk of EN (p<0.05):             No criteria for pro peg
Evaluating predictive factors for                                                                                            Poor performance status, advanced stage ca, smoking        placement, but all had 5-10%
determining enteral nutrition in patients               HNC patients having XRT       Pro PEG/NG n=30                        >20/d.                                                     wt loss.
                                                        in 2001                       Reactive PEG/NG n=20
receiving radical radiotherapy for head and
                                                                                                                             Pro EN minimises wt loss 0.7kg cf 3.4kg.
neck cancer: a retrospective review.                    N=160
Radiother Oncol 2006;78:152-8.                                                                                               Common sites of ca needing EN: oral and pharynx (40%
                                                                                                                             of pts – with 66-77% being pro).

Mantovani G, Maccio A, Bianchi A, et al.      III-2 Ø   Comparative Cohort, Italy     MA 320mg/d from day 3 post chemo       Weight post: mean increase +6.3 kg (13.2%)                 Pilot data.
Megestrol acetate in neoplastic                                                       to next cycle – for 3 cycles.          Appetite score post: mean increase +2.4 (38.6%)            Control group not described.
anorexia/cachexia: clinical evaluation and              N=11                                                                 PSK score post: mean increase -2.3 (-2.3%)
                                                                                      After cycle 1 - If no improvement to   QOL score post: mean increase +2.4 (36.2%)
comparison with cytokine levels in patients
                                                        HNC patients in an            appetite dose MA increased to
with head and neck carcinoma treated with               advanced (III-IV) stage of    480mg/d.                               Increase in weight in MA group c/w controls p<0.05
neoadjuvant chemotherapy. Int J Clin Lab                the disease, treated with
Res 1995;25:135-41.                                     Cisplatin based               After cycle 2 -                        No changes in haematological parameters or side effects.
                                                        neoadjuvant                   If wt >10% pre treatment weight
                                                        chemotherapy.                 reduce MA @ 160 mg/day or 320
                                                                                      mg/day in higher dose group.
                                                        Group 1 MA n=11               If wt gain < 10% or no increase, MA
                                                                                      cont @ 320mg or 480mg/day.
                                                        Group 2 control n=11
                                                                                      Antiemetic coverage for acute and
                                                        Treatment A (n= 5); high      delayed N&V.
                                                        dose Cisplatin + 5FU +
                                                        vinorelbine                   Assessment times:
                                                                                      • At enrolment
                                                        Treatment B (n=6): low        • At the end of each cycle of
                                                        dose Cisplatin + 5FU plus         chemo (every 21 days)
                                                        vinorelbine                   • At the end of the study (at 3
                                                                                          months)

                                                                                      Outcomes:
                                                                                      • Clinical response to chemo
                                                                                      • Weight
                                                                                      • Appetite
                                                                                      • PSK score
                                                                                      • QOL score
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                  Results                                                      Comments
                                               Quality
Mantsopoulos K, Zenk J, Konturek PC, Iro       IV Ø      Prospective Cohort Study     Intervention:                            No statistically significant difference between patients     Neither of the outcomes
H. Local infection after percutaneous                    Germany                      Prior to PEG insertion the abdominal     with and without peristomal infection with respects to       measured were clearly
endoscopic gastrostomy in ENT tumor                                                   wall thickness, subcutaneous layer       total wall thickness. There was also no relationship         defined and over what time
                                                         135 PEG insertions were      and muscle layer were measured           between age, gender, BMI, tumor staging or the               period.
patients: evaluation of the influence of the
                                                         investigated in 111          using ultrasonography.                   presence of diabetes.
abdominal thickness and other parameters.                patients.                    Nutritional status was also measured                                                                  Unclear statistics.
Med Sci Monit 2010;16:CR116-23.                                                       using Nutritional Risk Screening and
                                                         Dysphagic patients           BMI.
                                                         because of the head and
                                                         neck area or had             Outcomes:
                                                         radiotherapy were            Peristomal infection
                                                         included in the study.       Serious complications

Marcy PY, Magne N, Bensadoun RJ, et al.        IV Ø      Retrospective case series,   Peg insertion pre Rx (n=38/50) or        No major complications of PEG.                               Placement timing varied but
Systematic percutaneous fluoroscopic                     50 patients with stage 4     within 8 days of commencing Rx.          Minor complications 17 episodes in 40 patients PEG.          this should have had little
gastrostomy for concomitant                              SCC oropharynx and           Intake via PEG 8400kJ/day.               Mean wt ↑=2.5kg after 3 weeks of feeding.                    significant effect.
                                                         hypopharynx undergoing
radiochemotherapy of advanced head and
                                                         twice daily XRT +                                                     34% had BMI < 20 at presentation.
neck cancer: optimization of therapy.                    chemotherapy ( 3 courses
Support Care Cancer 2000;8:410-3.                        of Cisplatin) who had                                                 28 % had treatment induced mucositis after course 1 and
                                                         PEG insertion pre                                                     86% after course 2.
                                                         treatment.

Mattes RD, Curran WJ, Jr., Powlis W,           IV Ø      Case series, USA             Outcomes - Food aversions                    59% of patients formed new aversions.                    High attrition rates from 6
Whittington R. A descriptive study of                                                 (measured by questionnaires).                53% formed aversions to items in their customary         weeks post RT.
learned food aversions in radiotherapy                   N=49                                                                      diet.
                                                                                      Interviewed during the hour                  55% had pre-Rx food aversions (vegetables – 42%;         Small numbers for H&N.
patients. Physiol Behav 1991;50:1103-9.
                                                         Newly diagnosed cancer;      preceding their 1st course of RT and         red meat 27%; sweets 7%; fats 7%; dairy 7%;
                                                         undergoing RT (n=6 H&N       during the same period 3, 5, 7, 14, 21       caffeinated beverages 4%; alcohol 4%; spicy foods        Study population is
                                                         pts).                        and 28 days later then at 2, 4 and 6         2%).                                                     heterogeneous? Unlikely to
                                                                                      months post RT.                              6% developed an aversion to the halvah.                  extrapolate findings to the
                                                                                                                                   Among the pts who formed aversions, the median           H&N pt population
                                                                                                                                   no. of items targeted was 2.5 (1-20).                    specifically; particularly as
                                                                                                                                   A direct relationship between exposure frequency         CT was an exclusion criterion
                                                                                                                                   and aversion formation.                                  for this study which is known
                                                                                                                                                                                            to further increase taste
                                                                                                                               Range of aversive/eaten ratios is narrow but there is a      changes and food aversions.
                                                                                                                               strong significant correlation between the two
                                                                                                                               (Spearman=.92, p<0.0001).                                    References to blood tests to
                                                                                                                                                                                            assess nutritional status not
                                                                                                                                                                                            further elaborated on.

Matthews TW, Lampe HB, Dragosz K.              IV Ø      Prospective cohort, UK       Pre-treatment nutritional status         At baseline, 45% well nourished 52% malnourished.            Incorrect application of SGA
Nutritional status in head and neck cancer                                            measured using SGA.                           T stage correlated with baseline                        – if any one parameter
patients. J Otolaryngol 1995;24:87-91.                   N=42                                                                            o Diet intake P<0.036                              abnormal, considered to be
                                                                                      Outcomes:                                          o Diet type P<0.016                                nutritionally impaired.
                                                         SCC upper aerodigestive          Complications (systemic or                Stage IV correlated with baseline wt loss P<0.036
                                                         tract treated with surgery       local, major or minor)                    No baseline factors nor complications or survival
                                                         + RT                             Survival                                  found to be predictive/related to overall nutritional
                                                                                                                                    status
                                                                                                                                    Complications: Major 9.5%, Minor 38%
Citation                                       Level &   Study Design & Sample          Intervention & Outcomes               Results                                                        Comments
                                               Quality
Mayre-Chilton KM, Talwar BP, Goff LM.          IV Ø      Qualitative focus groups       Intervention: Focus groups            Knowledge: Lack of knowledge and understanding had             “The investigation shows that
Different experiences and perspectives                                                                                        an evident negative impact on the care-givers especially       a support process, involving
between head and neck cancer patients and                Patients were randomly         Outcomes:                             once they got home. There was an element of conflicting        multi-disciplinary specialists,
                                                         selected from a dietetic led   •    Knowledge and understanding      advice and omission of information which resulted in a         is required to guide head and
their care-givers on their daily impact of a
                                                         gastrostomy database at             of why the tube was necessary    negative impact on the patients. Overall, patients were        neck cancer patients and their
gastrostomy tube. Journal of Human                       UCLH Head and Neck                                                   more able to cope as they were the main focus of the           care-givers through the
Nutrition and Dietetics 2011; Jun 8. doi:                                               •    Strategies to cope with the
                                                         centre and invited to               feeding tube                     treatment and time had been dedicated to help them             treatment process together,
10.1111/j.1365-277X.2011.01165.x.                        participate.                                                         make an informed decision.                                     from diagnosis and the pre-
                                                                                        •    Differences in perceptions
                                                                                                                              Strategies: Both the patients and the care-givers              assessment clinic, before and
                                                                                        •    Objectives of oral nutritional
                                                         Patients diagnosed with                                              demonstrated the development of strategies to help them        during treatment to the
                                                                                             support
                                                         head and neck cancer,                                                cope with changes in their daily lives due to the PEG.         rehabilitation and re-
                                                                                        •    Preventing nutritional decline
                                                         who had a gastrostomy                                                Perceptions: Negative impact of perception and feelings        establishment of daily living
                                                         tube placed for nutritional    •    Gastrostomy tube dependency      of both groups, specifically for the social aspects of their   for long term survivorship.”
                                                         support undergoing cancer      •    Recognition of survival          lives and also their personal views of the situation and
                                                         treatment and with a           •    Support network                  how they perceived each other to feel. Care-givers:
                                                         minimum of three months                                              showed a greater negative impact of their perceptions
                                                         post tube placement, who                                             and feelings in relation to their daily activities. Intimacy
                                                         were well enough to                                                  was an issue which showed the sensitivity and
                                                         attend the session and give                                          difficulties experienced by both groups.
                                                         informed consent.                                                    Objectives: Patients expressed a dislike to the
                                                                                                                              nutritional supplements whereas the care-givers
                                                         n=9                                                                  expressed a positive view of supplements in helping
                                                                                                                              increase the calorie content.
                                                         Oropharynx = 2                                                       Preventing: Both groups found the main benefit and
                                                         Larynx = 2                                                           positive impact of the tube placement to be weight
                                                         Sarcoma mandible = 1                                                 management, care-givers articulated more of the
                                                         Unknown primary = 1                                                  negative impact of the weight loss prior to having the
                                                                                                                              tube being placed. Both groups expressed the
                                                         TX =1                                                                difficulties in weaning off the tube onto oral foods.
                                                         T1=2                                                                 Dependency: Both groups expressed many possible
                                                         T2=1                                                                 reasons for preventing them weaning off the gastrostomy
                                                         T3=1                                                                 tube onto normal foods. Timely dietetic management
                                                         T4=1                                                                 helped them wean off the tube reliance with more
                                                                                                                              confidence. Data highlights many influential factors
                                                                                                                              such as taste, smell, lack of saliva, pain, length of time
                                                                                                                              taken to eat, psychological concerns which the tube
                                                                                                                              feeding helps them to cope.
                                                                                                                              Survival: Both groups expressed a positive impact for
                                                                                                                              having the gastrostomy tube placed prior to any further
                                                                                                                              cancer treatment, as they recognised that they would not
                                                                                                                              have survived without it.
                                                                                                                              Support: Patients and care-givers expressed a positive
                                                                                                                              impact on approaching the hospital multidisciplinary
                                                                                                                              team, especially patients receiving radiotherapy who
                                                                                                                              attended weekly treatment multidisciplinary clinic,
                                                                                                                              where they had access to the registrar, dietitian, nurse,
                                                                                                                              and other professionals in one clinic. Dental extractions
                                                                                                                              in preparation for radiotherapy and dental rehabilitation
                                                                                                                              after treatment were expressed as a negative impact by
                                                                                                                              all participants. Some patients expressed a lack of active
                                                                                                                              care, after their treatment and discharge into the
                                                                                                                              community, to have a negative impact on them.
Citation                                     Level &   Study Design & Sample        Intervention & Outcomes                  Results                                                     Comments
                                             Quality
McLaughlin BT, Gokhale AS, Shuai Y, et       IV Ø      Case series, USA             G-tubes offered prior to initiating Rx        Median duration of G-tube placement was 5.8                G-tube placement not
al. Management of patients treated with                                             if wt loss >10%, progressive                  months (range 1.2-25.8 months).                            initiated until 10-15%
chemoradiotherapy for head and neck cancer             N=91                         dysphagia, aspiration risk and overall        At 6 and 12 months 15 (18%) and 4 (6%) pts who             wt loss.
                                                                                    nutritional status.                           were disease free were using G-tubes respectively.         Nutritional status is
without prophylactic feeding tubes: the
                                                       Consecutive records of                                                     Pts with G-tubes placed prior to CRT (p 0.039; HR          often referred to but no
University of Pittsburgh experience.                   patients undergoing CRT      Decision for G-tube placement during          0.38; 95%CI: 0.15-0.95) or advanced T stage                further detail or
Laryngoscope 2010;120:71-5.                            with curative intent,        Rx based on wt loss from baseline,            (p=0.015; HR 0.35; 95%CI 0.16-0.82) had longer             Dietitian/nutrition-
                                                       previously untreated H&N     dysphagia 2° Rx, evidence of                  G-tube dependence. (NB large CIs).                         specifics provided.
                                                       ca                           aspiration and overall nutritional            Descriptive: G-tube utilisation (n=80).                    Reference made to G-
                                                                                    status.                                       Never used 55 (60%); required G-tube placement             tube dependency as a
                                                       N= 69 1° CRT,                                                              36 (40%) i.e. 15 (16%) prior to CRT, 21 (23%)              surrogate measure of
                                                       n= 23 post-operative CRT     Outcomes:                                     during.                                                    dysphagia, however,
                                                                                        Timing and duration G-tube                G-tube present at 6/12 post CRT 15 (16%); 12/12            issues relating to return
                                                                                        placement                                 post 5 (5%).                                               to oral intake are often
                                                                                        Treatment-related complications           In disease-free pts 6/12 post CRT 15/82 (18%);             more complex than
                                                                                                                                  12/12 post 4/68 (6%) 24 months post 2/26 (8%).             inability to swallow.
                                                                                                                                  97% of G-tubes were endoscopically placed.                 G-tube duration was
                                                                                                                                  G-tube placement was safe with complications               longer in patients who
                                                                                                                                  uncommon (4/36 i.e. 11%).                                  received it prior to CRT
                                                                                                                                                                                             (due to presenting with
                                                                                                                                                                                             >10% wt loss,
                                                                                                                                                                                             dysphagia/aspiration
                                                                                                                                                                                             etc) and those with
                                                                                                                                                                                             advanced stage disease
                                                                                                                                                                                             → it would seem these
                                                                                                                                                                                             patients are the ones
                                                                                                                                                                                             with a higher degree of
                                                                                                                                                                                             nutritional compromise
                                                                                                                                                                                             hence would require
                                                                                                                                                                                             nutrition support for a
                                                                                                                                                                                             longer period.


McRackan TR, Watkins JM, Herrin AE, et       III-3 Ø   Prognosis retrospective      Chart review to investigate the               Pts with normal or low BMI (<25) were                     Groups normal wt with
al. Effect of body mass index on                       cohort, USA                  association between initial BMI and           significantly more likely to be PEG dependent at          underweight pts
chemoradiation outcomes in head and neck                                            chemoradiation therapy (CRT)                  last f/u (OR 4.13, 95%CI: 1.3-12.9; p=0.014).             BMI as a marker of
                                                       N=72                         outcomes                                      This group also had significantly earlier recurrence      nutritional status.
cancer. Laryngoscope 2008;118:1180-5.
                                                                                    BMI <25 n=42 , or BMI>25 n=30                 (HR 3.6; 95%CI: 1.04-12.6), p=0.043). Overall             Pts with lower BMI had
                                                       Pts with Stage III or IV                                                   mean duration of PEG dependence was 13 months             PEG tubes longer but
                                                       SCC of oropharynx,           Mean duration of f/u 2.2 yrs post             (14.8 months for BMI<25; 11 months for                    likely nutrition support
                                                       hypopharynx or larynx        CRT (range 5.9 months – 4.8yrs).              BMI>25).                                                  was probably warranted
                                                       treated with 1° concurrent                                                 BMI was the only factor investigated that had             for a longer period
                                                       CRT with curative intent     Age, sex, race, smoking, EtOH                 significant association with PEG status at last f/u.      Paper does acknowledge
                                                       over 5 year period.          history, tumour site/stage, disease-          When evaluated as a continuous variable, BMI had          these limitations
                                                                                    free survival (CFS), overall survival         an OR of 0.79 (95%CI 0.69-0.91; p=0.0013)                 including? HPV positive
                                                                                    (OS). For PEG patients: duration of                                                                     tumours a confounding
                                                                                    tube placement and PEG dependence        → Pts 1.3 x more likely to be PEG dependent at last f/u        factor in higher BMI and
                                                                                    at last f/u.                             for every unit decrease in BMI.                                DFS.
Citation                                      Level &   Study Design & Sample          Intervention & Outcomes                    Results                                                       Comments
                                              Quality
Medina JE, Khafif A. Early oral feeding       III-3 Ø   Cohort study with              Intervention group (n=55): early oral      Fistula rate (NS)                                             Intervention group consisted
following total laryngectomy. Laryngoscope              historical control, USA        feeding - 48hrs post op commenced          Early; 2/55 (3.6%). Late: 2/19 (11%)                          of 2 recruitment phases. 1st
2001;111:368-72.                                                                       liquid diet and progressed to soft diet.                                                                 phase was compared to
                                                        N=73                                                                      Pharyngeal stricture (NS):                                    control for baseline but
                                                                                       Control group (N=19): late oral            Early: 3/55 (5.5%). Late: 2/19 (11%)                          pooled group was not.
                                                        Total laryngectomy for a       feeding - NBM for 7-10 days post op,
                                                        malignant neoplasm             then commenced liquid diet and             LOS (p<0.0001)
                                                        involving the larynx, with     progressed to soft diet.                   Early: 7.0 days. Late: 11.8 days
                                                        follow-up 6- to 8-week
                                                        intervals for the first year   Outcomes:
                                                        for a minimum of 6                 LOS
                                                        months.                            Fistula rates
                                                                                           Stricture rates

Mekhail TM, Adelstein DJ, Rybicki LA,         IV Ø      Retrospective audit            N/g + PEG=91 (57%):                        Female gender (p=0.031), hypo pharyngeal primary (            Explains potential bias –
Larto MA, Saxton JP, Lavertu P. Enteral                                                29 N/g vs. 62 PEG                          p=0.041) and T4 (p= 0.032), CRT vs. RT alone (                selection of NG or PEG
nutrition during the treatment of head and              n=158                                                                     p<0.001) significantly more likely to need alternative        affected by dr or pt
                                                                                       Outcomes:                                  feeding.                                                      preference or experience -
neck carcinoma: is a percutaneous
                                                        Chemotherapy or                    Mucositis                                                                                            PEG may have been placed in
endoscopic gastrostomy tube preferable to a             radiotherapy for all SCC           Dysphagia                              Dysphagia statistically more persistent at 3 and 6 months     more malnourished or in
nasogastric tube? Cancer 2001;91:1785-90.               head and neck pts.                 Duration of tube dependence            in the PEG pts (p=0.015) but not at 12/12.                    those expected to need
                                                                                           Need for pharyngoesophageal                                                                          feeding for longer.
                                                                                           dilatation                             Median feeding tube time=28 weeks with PEG vs. 8
                                                                                                                                  with N/G.                                                     Are NG pts more motivated
                                                                                                                                                                                                with rehab due to tube
                                                                                                                                  PEG feeding and CRT more likely to require dilatation         discomfort & appearance?
                                                                                                                                  (possibly d/t lack of NG as a stent).

Mercuri A, Lim Joon D, Wada M, Rolfo A,       III-2 -   Comparative cohort,            N=10 had PEGs,                             PEG pts lost less weight (p=0.04) over the course of RT           Small study.
Khoo V. The effect of an intensive                      Australia                      N=10 no PEG (or NG)                        (Non-PEG lost mean 2.6kg more weight) and had a                   Good to see a paper
nutritional program on daily set-up                                                    Peg placement by dedicated                 reduction in set-up variation in the superior-inferior (SI)       investigating how
                                                        N=20                           gastroenterologists according to local     and anterior-posterior (AP) planes compared to those              nutrition can impact on
variations and radiotherapy planning
                                                                                       guidelines:                                without.                                                          important aspects of care
margins of head and neck cancer patients. J             Non-metastatic H&N             1) Pre-existing dysphagia                                                                                    e.g. ensuring optimum
Med Imaging Radiat Oncol 2009;53:500-5.                 SCC; prescribed 6-7            2) Compromised dietary intake              In this study no patient developed infection or major             delivery of anti-
                                                        weeks 3D conformal RT.              resulting in >10% wt loss prior       complication through use of the PEG tube and may be               oncological treatments.
                                                                                            to RT                                 due to the fact all PEG tubes were inserted by a                  Authors do not include a
                                                                                       3) Concurrent chemo                        dedicated gastroenterology unit utilising endoscopy               Dietitian or inclusion of
                                                                                       4) Bilateral neck irradiation              (whereas other studies have found high infection                  additional nutrition
                                                                                       Outcomes:                                  rates/toxicity associated with PEG). Indicates incidence          assessment parameters
                                                                                       Wt - start of RT (Baseline), wk3-4,        of PEG tube complications may be operator dependent               although there is some
                                                                                       wk 6-7.                                    and also underlies need for dedicated experienced                 reference to this in
                                                                                       Planning target volume (PTV) – daily       personnel.                                                        discussion.

Meyer F, Bairati I, Jobin E, et al. Acute     II Ø      RCT – double blinded,          1.   400IU a-tocopherol + 30mg b-          Fewer adverse side effects with:                              Note – b-carotene ceased
adverse effects of radiation therapy and                multi-centre, Canada                carotene                                  Higher b-carotene diet intake OR 0.61                     after 156 pts due to concerns
local recurrence in relation to dietary and                                            2.   Placebo                                   Higher plasma b-carotene levels                           with safety following other
                                                        N=540                                                                     OR 0.73                                                       reported trials.
plasma beta carotene and alpha tocopherol                                              Supplements taken for duration of RT
                                                                                                                                  Improved survival with:
in head and neck cancer patients. Nutr                  Stage I and II H&N SCC
                                                                                       and 3 years post with median follow-
                                                                                                                                      Higher plasma b-carotene levels
Cancer 2007;59:29-35.                                                                  up of 52 months
                                                        having RT.                                                                OR 0.67
                                                                                       Outcomes:
                                                                                                                                  No effect of a-tocopherol on adverse effects or survival
                                                                                            RT adverse effects
                                                                                                                                  NS.
                                                                                            Recurrence
Citation                                        Level &   Study Design & Sample         Intervention & Outcomes                Results                                                     Comments
                                                Quality
Meyer F, Bairati I, Fortin A, et al.            II +      RCT – double blinded,         1.   400IU a-tocopherol + 30mg b-      Smoking and supplement use before or after RT no            Note – b-carotene ceased
Interaction between antioxidant vitamin                   multi-centre, Canada               carotene                          effect on outcomes.                                         after 156 pts due to concerns
supplementation and cigarette smoking                                                   2.   placebo                                                                                       with safety following other
                                                          N=540                                                                Smoking and supplements during RT had increased risk        reported trials.
during radiation therapy in relation to long-                                           Supplements taken for duration of RT
                                                                                                                               of:
term effects on recurrence and mortality: a               Stage I and II H&N SCC
                                                                                        and 3 years post.
                                                                                                                                   Recurrence (HR 2.41)
randomized trial among head and neck                                                    Post hoc analysis of smoker vs. non
                                                          having RT.                                                               All cause mortality (HR 2.26)
cancer patients. Int J Cancer 2008;122:1679-                                            smoker for each group.
                                                                                                                                   HN cause mortality (HR 3.38)
83.                                                                                     Outcomes:
                                                                                             Recurrence
                                                                                                                               Non smokers and supplements had no significant
                                                                                             Mortality
                                                                                                                               increased or decreased risk.
Meyer F, Liu G, Douville P, et al. Dietary      IV +      Prognosis study, cohort of        Pts randomised to either           • No significant association between dietary or serum
vitamin D intake and serum 25-                            a phase 3                         vitamin E/beta carotene or             vitamin D status and the 3 outcomes.
hydroxyvitamin D level in relation to                     chemoprevention trial,            placebo
                                                          Canada                            Baseline vitamin D status
disease outcomes in head and neck cancer
                                                                                            measured prior to RT
patients. Int J Cancer 2011 Apr                           N=540                         Outcomes:
1;128(7):1741-6 doi: 101002/ijc25496 Epub                                               •   HNC recurrence
2010 Jun 7 2011.                                          Stage I or II head and neck   •   Second primary cancer
                                                          cancer patients receiving         incidence
                                                          radiotherapy.                 •   Mortality

Mick R, Vokes EE, Weichselbaum RR,              IV Ø      Case series, USA              Study A: Three drug regimen            CR = 29%
Panje WR. Prognostic factors in advanced                                                Cisplatin, 5-FU and methotrexate       Overall response rate (CR + PR) = 82%
head and neck cancer patients undergoing                  N= 80 (study A 38, Study      with leucovorin.
                                                          B 42)                         Study B: Two different induction       38% 3 year survival rate - median 23.7 months
multimodality therapy. Otolaryngology
                                                                                        regimens either Cisplatin, 5-FU,
Head and Neck Surgery 1991;105:62-73.                     Locally advanced stage III    methotrexate with leucovorin rescue    Survival predictors:
                                                          or IV SCC H&N having          OR two alternating cycles of           Pre treatment Weight loss P<0.0001.
                                                          neoadjuvant                   Cisplatin, bleomycin, methotrexate     N stage P=0.019.
                                                          chemotherapy (pre surgery     and leucovorin followed by Cisplatin   Alcohol use P=0.017.
                                                          and/or RT).                   and 5-FU.                              No pre treatment wt loss – median survival 44.3 months.
                                                                                        Outcomes:                              >10% re treatment wt loss – median survival 10.6
                                                                                             Response rates                    months.
                                                                                             Early deaths
Mills EE. The modifying effect of beta-         II Ø      RCT, South Africa             1.    b-carotene 250mg/d for 21days,   b-carotene group had:
carotene on radiation and chemotherapy                                                        then 75mg/d for duration of      Less severe mucositis P<0.025
induced oral mucositis. Br J Cancer                       N= 20                               treatment
                                                                                        2.    nil
1988;57:416-7.
                                                          SCC mouth receiving           Outcomes:                              No difference in remission or survival rates between
                                                          synchronous CRT.                   Mucositis                         groups NS.
                                                                                             Remission
Morton RP, Crowder VL, Mawdsley R, Ong          IV Ø      Case series, new Zealand      83% had PEG before Rx or within        Median PEG duration = 225 days (range 60-900).              Confirms the assoc b/t poor
E, Izzard M. Elective gastrostomy,                                                      1/12 of commencement.                    Only 2 pts (6%) were tube free at completion of Rx,       function( speech, diet,
nutritional status and quality of life in                 N=36                                                                   increased to 26 (72%) at 12/12, but only 10/26 could      swallow, eating in public) &
                                                                                        Outcomes 18-24 months after              manage a normal diet at this stage.                       PEG duration & assoc QOL.
advanced head and neck cancer patients
                                                          Pts who received CRT for      diagnosis:                               At time of follow-up 17 (47%) normal diet (16 were
receiving chemoradiotherapy. ANZ J Surg                   curative Rx of advanced           Performance Status,                  at least 2 yrs post-completion), 2 still had PEG inset.
2009;79:713-8.                                            HNC.                              Functional measure of                Saliva= lowest (worst) QOL domain, followed by
                                                                                            swallowing,                          swallowing, taste, chewing.
                                                                                            Nutritional mode                     Timing of PEG insertion did not predict nutrition
                                                                                            QOL                                  mode.
                                                                                            PEG dependence                       Overall QOL correlated with current PEG feeding
                                                                                                                                 status.
Citation                                     Level &   Study Design & Sample        Intervention & Outcomes                  Results                                                    Comments
                                             Quality
                                                                                                                             Mean wt loss was 6.4kg (77 to 71.6kg) =7%.
                                                                                                                             Wt loss was correlated with HRQOL (p=0.026).
                                                                                                                             % wt loss, fall in BMI at 12/12 was significant assoc to
                                                                                                                             PEG insertion time (p=0.049): within 1/12 of Rx vs.
                                                                                                                             >1/12.
                                                                                                                             There was a consistent correlation between poor
                                                                                                                             function (speech, diet, swallow, eating in public) & PEG
                                                                                                                             duration.


Moor JW, Patterson J, Kelly C, Paleri V.     IV Ø      Web-based questionnaire      Intervention:                            •     PEG most commonly available: 96%
Prophylactic Gastrostomy before                        of UK health professionals   nil. Indicators for prophylactic PEG     •     57% state protocol in place.
Chemoradiation in Advanced Head and                    who regularly attend pts     insertion pre-chemoXRT                   •     When compared by profession, there was no
                                                       with advanced HNSCC                                                         significant difference between AHPs’ and medical
Neck Cancer: a Multiprofessional Web-
                                                       via email to affiliate       Outcomes:                                      professionals’ responses for how frequently their
based Survey to Identify Current Practice              organisations (i.e. Royal    n/a                                            MDT recommends G-tube insertion at any subsite.
and to Analyse Decision Making. Clinical               College of Speech and                                                 •     However, significantly more medical
Oncology 2010;22:192-8.                                Language Therapists                                                         professionals ‘rarely’ or ‘never’ recommend G-
                                                       speciality interest group,                                                  tube insertion for larynx carcinoma (P=0.04) and
                                                       British Dietetic                                                            more AHPs ‘rarely’ or ‘never’ recommend G-
                                                       Association oncology                                                        tubes for oropharyngeal carcinoma compared with
                                                       group, the head and neck                                                    medical professionals, but not significant
                                                       group of the British                                                        (P=0.07).
                                                       Association of                                                        •     4 factors that are clearly considered most
                                                       Otolaryngologists-Head                                                      important (pre treatment swallowing function, pre
                                                       and Neck Surgeons and                                                       treatment weight loss, low body mass index,
                                                       the British Association of                                                  patient choice) and two factors felt to be least
                                                       Head and Neck Oncology                                                      important (cosmesis, alcohol dependency).
                                                       Nurses).                                                              •     47% of AHPs were uncertain as to the effect of a
                                                                                                                                   G-tube compared with 33% of medical
                                                       Responses assumed                                                           professionals. 12% of AHPs compared with 33%
                                                       unknown primary.                                                            of medical professionals thought it would have an
                                                                                                                                   adverse effect, 28% of AHPs compared with only
                                                       N=137 (25% response                                                         11% of medical professionals thought it had a
                                                       rate), exclude 7 who were                                                   positive effect and 12% of AHPs compared with
                                                       not regularly involved in                                                   22% of medical professionals felt it made no
                                                       HNSCC.                                                                      difference. Overall, the differences in opinion
                                                                                                                                   between AHPs and medical professionals were
                                                                                                                                   statistically significant (chi-squared test, P =
                                                                                                                                   0.009).

Munshi A, Pandey MB, Durga T, Pandey         IV Ø      Case series, India           Chart audit and analysis of factors to   Three factors found significant for >5kg wt loss (χ2):
KC, Bahadur S, Mohanti BK. Weight loss                                              investigate which factors were                Low initial KPS (p<0.001)
during radiotherapy for head and neck                  N=140                        causative in pts with absolute wt loss        Use of CRT (p<0.001)
                                                                                    >5kg and relative wt loss of >10%.            Total RT dose >60Gy (p=0.04)
malignancies: what factors impact it? Nutr
                                                       H&N ca, treated with
Cancer 2003;47:136-40.                                 radical RT, concurrent       NGT placed when required due to          Factors found significant for >10% wt loss(χ2):
                                                       CRT, PORT.                   dysphagia.                                    Low initial KPS (p<0.001)
                                                                                                                                  Use of CRT (p<0.001)
                                                                                    Outcome: Weight – weekly                 74% of pts had >10% wt loss at end of RT
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes                  Results                                                   Comments
                                              Quality
Murphy BA, Dietrich MS, Wells N, et al.       III-2 Ø   Diagnostic study, USA       Survey developed based on                VHNSS is a brief self-administered instrument that
Reliability and validity of the Vanderbilt                                          commonly reported symptoms.              assesses head and neck specific symptoms and function
Head and Neck Symptom Survey: a tool to                 Development: n=26 and       Tool Validation                          loss.
                                                        n=23                        5 studies looking at different           Takes less than 5 minutes to complete.
assess symptom burden in patients treated
                                                        Validation: n=332           components and comparing results to      Demonstrated appropriate concordance with commonly
with chemoradiation. Head Neck                                                      other ax tools.                          validated measures to assess H+N symptom burden and
2010;32:26-37.                                          Patients with HNC either         Diet Adaptation                     QOL. There was also concordance with objective
                                                        during or post CRT.              Resource Utilization Assessment     measures such as modified barium swallow studies,
                                                                                         Coping Styles in patients with      resource utilization and nutritional status.
                                                                                         H+N cancer and significant          Tool designed to provide timely and focused assessment
                                                                                         others                              of symptom burden allowing health care providers to
                                                                                         Modified Barium Swallow             respond to the dynamic needs of this population.
                                                                                         Study
                                                                                         Energy Balance Study
Myssiorek D, Siegel D, Vambutas A.            IV -      Case series, USA            FPG insertions and complication             All PFG insertions completed as day case and with
Fluoroscopically placed percutaneous                                                rates.                                      local anaesthetic only
gastrostomies in the head and neck patient.             N=25                                                                    Minor complications n=2 (n=1 tube dislodgement,
                                                                                                                                n=1 tube replacement due to discomfort)
Laryngoscope 1998;108:1557-60.
                                                        Pts having fluoroscopic                                                 No major complications
                                                        percutaneous gastrostomy                                                Cost of PFG $500 vs. cost of PEG $2570
                                                        (FPG) insertion with H&N
                                                        cancer.
Navarro Vila C, de la Mano JS, Garcia Peris   IV Ø      Case series, Spain          Post op enteral feeding – continuous.    Complications:
P, Acero Sanz J, Barrios Robredo JM,                                                Goal rate determined using Harris        Diarrhoea n=8, Aspiration pneumonia n=1
Verdaguer Martin JJ. Enteral nutrition in               N=30                        Benedict.                                Nutritional status:
                                                                                                                             Average wt loss 1.2-1.8kg
patients with tumours of the head and neck.
                                                        HNC patients treated with   Measurements of nutritional status at    TSF fell 5.9%
J Craniomaxillofac Surg 1989;17:34-8.                   surgery and required post   baseline and end of period of EN.        MAMC fell 3.4%
                                                        op enteral feeding for                                               Albumin & transferrin -
                                                        >7days.                                                              Normal at baseline and no change during EN
Nayel H, el-Ghoneimy E, el-Haddad S.          II Ø      RCT, Egypt                  Grp 1 = RT alone (n=12) or                   All pts who received nutritional supplementation      Pts randomized (regardless of
Impact of nutritional supplementation on                                            Grp 2 = RT + HPHE oral nutritional           experienced an increase in body wt and in triceps     pre-treatment nutrition
treatment delay and morbidity in patients               N=23                        supplements (ONS) i.e. Ensure                skin-fold thickness, whereas 58% of non-              status)
                                                                                    (n=11).                                      supplemented group had wt loss (p=0.001).                  Small study.
with head and neck tumors treated with
                                                        Pts with H&N cancer                                                      Irradiation had to be suspended in 5/12 of the non-        Older paper with
irradiation. Nutrition 1992;8:13-8.                     treated with RT             Nutrition status assessed subjectively       supplemented group 2 ° severe mucosal reaction             questionable dietary
                                                                                    and objectively weekly during RT.            and/or poor performance status (4 for <10d, 1              methodology. Note use
                                                                                                                                 >2wk). 9% of those received ONS but was not                of older RT
                                                                                    Outcomes:                                    statistically significant.                                 technology∴?
                                                                                    Anthropometry: wt(kg), ht (cm),              All pts who received nutritional supplementation           Relevant/applicable in
                                                                                    MAC/TSF (mm)                                 during RT completed course of Rx without                   current setting of
                                                                                    Mucosal reaction score                       interruption.                                              conformal RT/IMRT.
                                                                                                                             Subjective Nutrition Ax:                                       Concern re ethics of
                                                                                                                                   By Wk 4 (40Gy) 91% pts experienced dry mouth.            randomizing people to
                                                                                                                                   By Wk 5 (50Gy) 70% pts reported taste changes            RT or RT + nutritional
                                                                                                                                   and loss of appetite.                                    supplements regardless
                                                                                                                                   % of pts with swallowing problems was higher in          of baseline nutritional
                                                                                                                                   RT alone vs. RT+ONS group (92% vs. 73%).                 status.
                                                                                                                             Mucosal Reaction:                                              Dietary methodology
                                                                                                                             No pt in RT+ONS experienced Grade III mucosal                  utilised not good enough
                                                                                                                             reaction whereas 25% of RT alone group had Grade III           quality to be a
                                                                                                                             functional and mucosal reactions.                              particularly strong study.
                                                                                                                             Objective Nutrition Ax *all significant (p=0.001):
                                                                                                                             Wt -2%, +5% MAC/TS -1%, +4%
Citation                                      Level &   Study Design & Sample         Intervention & Outcomes                  Results                                                   Comments
                                              Quality
Neeff M, Crowder VL, McIvor NP, Chaplin       III-2 Ø   Comparative cohort, NZ        PEG or PRG insertion with f/up 30           Overall co rate PEG 11% PRG 44% p=0.0004               Insertions were at different
JM, Morton RP. Comparison of the use of                                               days post placement.                        Minor complication rate PEG 7% PRG 39%                 times for each group i.e. PEG
endoscopic and radiologic gastrostomy in a              N= 74 (PEG 56, PRG 18)                                                    Major complication rate PEG 3.6% PRG 5.6%              mostly pre/during Rx, PRG
                                                                                      Outcomes:                                   Delay in feeding PEG 4% compared to PRG 39%            mostly during/post Rx.
single head and neck cancer unit. ANZ J
                                                        All initial PEG or PRG            Total complications                     p<0.025
Surg 2003;73:590-3.                                     insertions in H&N                 Minor complications (leak,              Success rate PEG 89% (7/63 failed attempts)            Acknowledged bias (high %
                                                        patients.                         infection, N&V, ileus, bleeding)        compared to PRG 100% (no failed attempts)              of palliative patients in PRG
                                                                                          Major complications                     No deaths related to procedure in either group.        group).
                                                                                          (peritonitis)                           Total deaths in study period: PEG 30 (54%) and
                                                                                          Delay in resumption of feeding          PRG 14 (78%)

                                                                                                                               No metastatic seeding seen in either group.
Newman LA, Vieira F, Schwiezer V, et al.      IV Ø      Case series, USA              Outcomes:                                   Significant wt loss occurred during the targeted CRT         Supports evidence for
Eating and weight changes following                                                   Weight and eating status.                   protocol (p<0.001) with a mean wt ration of 90% of           ongoing wt loss post-Rx
chemoradiation therapy for advanced head                N=47                                                                      the starting wt.                                             (and hence need for
                                                                                      Wt: Pre-Rx; end of Rx; and at 6, 12,        Repeated measures analysis of variance revealed a            ongoing dietetic input
and neck cancer. Arch Otolaryngol Head
                                                        Pts enrolled in the           18 months post Rx.                          significant wt loss (P<0.001) during RADPLAT Rx              although this is not
Neck Surg 1998;124:589-92.                              RADPLAT protocol from                                                     with a mean wt loss 10% (+6%); range 78-102% of              stated in the paper).
                                                        June 1993-Dec 1994 for        Eating ability was categorised as: 1)       initial body wt.                                             The findings of this
                                                        Rx of advanced HNC.           normal or nearly normal swallowing,         Significant relationship between the ability to eat          study are relevant to the
                                                                                      2) impaired swallowing, 3)                  and tumour stage.                                            described RADPLAT
                                                                                      recreational oral intake (dependent on      Percentage of pts who reported normal swallowing             protocol → may need to
                                                                                      tube feeding for nutritional                declined during RADPLAT Rx from 38% (18 pts) to              interpret with caution
                                                                                      requirements and eating occasionally        21% (10pts) and increased during the next 18 mo to           and avoid extrapolation
                                                                                      by mouth, 4) entirely dependent on          72% (34pts).                                                 of findings to all Rx
                                                                                      tube feeding.                               At start of Rx 4 pts (9%) had PEG tubes; at                  protocols (i.e. is this
                                                                                                                                  completion 12 pts (26%) had PEG tubes. At 6, 12,             considered current gold
                                                                                                                                  18 mo post Rx, need for PEG tube dropped to 13%              standard CT regime –
                                                                                                                                  (6pts).                                                      including the parenteral
                                                                                                                                                                                               sodium thiosulfate? ?
                                                                                                                                                                                               Med Onc r/v to
                                                                                                                                                                                               confirm.
Ng K, Leung SF, Johnson PJ, Woo J.            IV +      Case series, Hong Kong        Standard treatment regarding                  Mean BMI at end RT was 21.5+3.7kg/m2 (range          Note standard Rx in NPC in
Nutritional consequences of radiotherapy in                                           nutritional support, which includes:          13.7+27.9) was significantly lower than at T0        this group was largely RT
nasopharynx cancer patients. Nutr Cancer                N=38                                                                        (P<0.001).                                           alone whereas standard of
                                                                                          Explanation of expected acute             Body wt at T1-T3 was significantly lower than at     care in Australia is
2004;49:156-61.
                                                        Pts scheduled for curative-       side effects of RT by physician           T0 (P<0.001).                                        concurrent CRT +/- adjuvant
                                                        intent RT for                     and weekly review,                        Mean % wt loss was 10.8% at end-RT.                  CT.
                                                        nasopharyngeal carcinoma          Attendance at group nutrition             55% of pts (20/30) had > 10% wt loss by end of
                                                        (NPS).                            counselling sessions pre RT               RT.
                                                                                          Encouraged to take milk                   BMR corrected for body weight did not change
                                                                                          supplements                               significantly among the 4 time points but BMRs
                                                                                          Prophylactic tube feeding not             corrected for LBM at T2 and T3 were significantly
                                                                                          offered.                                  lower than at T0 (P<0.01).
                                                                                                                                    Calorie intake generally declined from T0 to T1
                                                                                      Outcomes:                                     (1857+411kcal to 1168+549kcal) (P<0.001).
                                                                                      Wt, body composition, BMR, calorie            Calorie intake at T2 to T3 were not significantly
                                                                                      intake, TEE.                                  different from T0 but were significantly higher
                                                                                                                                    than T1.
                                                                                      Time points:                                  Body Fat Mass and LBM at the different time
                                                                                      T0 – pre-RT                                   points post-RT were significantly lower than at
                                                                                      T1 - end-RT                                   pre-RT (P<0.001). During recovery from end RT
                                                                                      T2 - 2mo post-RT                              to 6mo post-RT LBM remained largely static
                                                                                      T3 - 6mo post-RT                              whereas fat mass continued to decrease.
Citation                                     Level &   Study Design & Sample         Intervention & Outcomes                 Results                                                   Comments
                                             Quality
                                                                                                                                  Pts were in negative energy balance before, during
                                                                                                                                  and up until 6 months after RT.
                                                                                                                                  Pts were in negative energy balance (600kcal
                                                                                                                                  deficit/d) at both pre-RT and post-RT time points.
                                                                                                                                  Recovery in body weight lagged behind the
                                                                                                                                  recovery of dietary intake.
                                                                                                                                  Mean TEE at pre-RT was 2494+729kal/d. A
                                                                                                                                  significant reduction was seen at end-RT
                                                                                                                                  (P<0.001). TEE increased significantly between
                                                                                                                                  end-RT and 2 and 6 mo post end-RT although did
                                                                                                                                  not return to pre-RT level.
                                                                                                                                  Only 26% of pts had energy intake >80% EER
                                                                                                                                  (using 1.5xBMR).

Nguyen NP, Moltz CC, Frank C, et al.         IV Ø      Case series, USA              G tube placed prior to treatment.       Acute toxicity grade 3-4:
Dysphagia following chemoradiation for                                                                                       Mucositis n=45
locally advanced head and neck cancer. Ann             N=55                          Outcomes:                               Haematological n=42
                                                                                     Toxicity                                Aspiration pneumonia n=3
Oncol 2004;15:383-8.
                                                       Stage III-IV HNC treated      Wt loss                                 Wt loss 0-21kg (mean 8kg)
                                                       with concurrent CRT.          Treatment delays                        Survival at 17months – 78%
                                                                                                                             Severe dysphagia n=25 (45%) – prolonged tube feeding
                                                                                     Time points                             >3 months n=22, repeated dilatations n=3.
                                                                                     Weekly during RT                        Tube feeding duration 4 to 21 months (median 9 month).
                                                                                     Monthly f/up post                       Increased dysphagia with site (o, op, p, np, l, ukp) +
                                                                                                                             CRT.
                                                                                                                             Baseline MBS to plan rehab and to detect silent
                                                                                                                             aspiration.
                                                                                                                             Early exercises to prevent long term dysphagia.
                                                                                                                             Swallow as long as possible/safe to do so.

Nguyen NP, North D, Smith HJ, et al.         IV Ø      Case series, USA              PEG feeds pre-Rx if poor oral intake    All developed mucositis: 90/104 (85%) developed Grade     Limitation is not presenting
Safety and effectiveness of prophylactic                                             or aspiration on MBS, otherwise         3-4 mucositis.                                            base line weights. Outcomes
gastrostomy tubes for head and neck cancer             N=104                         continue oral feeding until they                                                                  document severe malnutrition
                                                                                     developed dysphagia & mucositis.        98% lost wt: mean= 8.5kg.                                 (10%) wt loss despite
patients undergoing chemoradiation. Surg
                                                       Stage III & IV H&N ca                                                                                                           nutrition intervention.
Oncol 2006;15:199-203.                                 undergoing CRT (5FU           For the first 3 years?? of the study:   Tube feeding cont 1-41 /12 post Rx, mean= 8 months,
                                                       and cisplat). Prior to Rx -   Advised to cont PEG feeding until       median= 5/12.
                                                       Dental extraction,            resolution of acute mucositis allowed
                                                       nutrition Ax, placement of    them to resume oral diet, then          9pts required PEG in the beginning of Rx.
                                                       PEG pre-Rx.                   advised to delay until they had a
                                                                                     swallowing study post-RX:               10 pts developed chronic aspiration & became
                                                                                     Pts with proven aspiration/chronic      permanently tube dependent.
                                                                                     dysphagia/continued wt loss
                                                                                     continued tube feedings.                1 pt declined PEG, lost 20kg during RX, also developed
                                                                                     A dietitian monitored wt &              ARF.
                                                                                     nutritional status.
                                                                                     Outcomes:                               PEG complications: 1 PEG site infection, 2 leakage
                                                                                     • Toxicity (RTOG scale)                 (requiring replacement).
                                                                                     • Wt loss
                                                                                     • Rx delays
                                                                                     • Repeat endoscopy at follow-up

                                                                                     Follow-up 1-62 months, median =19
                                                                                     months.
Citation                                      Level &     Study Design & Sample         Intervention & Outcomes               Results                                                      Comments
                                              Quality
Nguyen NP, Vos P, Vinh-Hung V, et al.         IV Ø        Retrospective review (case    Intervention:                         •   91 (85%) experienced grade 3-4 mucositis during Tx       • The 6 patients who
Altered glucose metabolism during                         series), Arizona, US          Prophylactic PEG prior to treatment       resulting in weight loss (median 7.2 kg) and               developed diabetes
chemoradiation for head and neck cancer.                                                5FU (1000 mg/m2) on days 1-4 and          treatment breaks (median: 13 days).                        following treatment may
                                                          Patients with locally         21-24 & CDDP 100 mg/m2 on day 1       •   Non-fasting serum glucose range pre treatment 62-          suffer from insulin
Anticancer Research 2009;29:4683-7.
                                                          advanced H&N Ca who           and 21 of RTx (total dose 3960-4000       207mg/dL (mean: 102).                                      deficiency secondary to
                                                          underwent concurrent          cGy).                                 •   Serum glucose elevation reached statistical                CDDP administration.
                                                          chemoRTx between May                                                    significance during weeks 5,6,7,8 for the non            • H&N Ca chemoRTx may
                                                          1999 and Feb 2006 at the      Outcomes:                                 diabetic group (p= 0.003, 0.007, 0.009, and 0.01           induce glucose
                                                          Veterans Administration       •   CBC, glucose, electrolytes,           respectively).                                             metabolism alterations.
                                                          Health Care System.               blood urea nitrogen and Creat     •   11 non-diabetic patients had serum glucose levels          Diabetes may develop
                                                                                        •   Non-fasting BSL (>200 mg/dL           exceeding 200 mg/dL during treatment.                      during and/or after
                                                          Range 34-86 years of age          considered diabetic)              •   10 patients were treated with insulin to reduce            treatment. Consequently
                                                          (median 59 years)             •   Toxicity (assessed using              hyperglycaemia, 2 of these patients died (1 due to         BGLs should be
                                                          105 male, 1 female                Radiation therapy Oncology            hyperosmolar coma following aspiration                     monitored during and
                                                          85 Caucasian                      Group (RTOG) toxicity scale           pneumonia).                                                following Tx.
                                                          21 African-American           •   Weight loss                       •   1 patient with hyperosmolar coma was treated with
                                                                                        •   Treatment delays and side             insulin and hydration.
                                                          (Stage: 2=1, 3=31, 4a =           effects                           •   BGL normalised post treatment in 6 patients, 3
                                                          55, 4b = 18, recurrence =     •   Diabetes                              remained diabetic.
                                                          2)
                                                                                                                              •   3 patients who did not reach diabetic BGL range
                                                          105 cases SCC, 1 case
                                                                                                                                  during Tx developed diabetes post Tx.
                                                          basaloid carcinoma
                                                                                                                              •   6 non-diabetic patients developed diabetes post-Tx
                                                          Karnofsky performance
                                                                                                                                  requiring OHAs.
                                                          status (PS) >70%
                                                          Diabetes prior to Tx (Y =                                           •   10% patients encountered nutritional problems;
                                                          15, N= 91)                                                              median weight loss 7.2kg.




Nourissat A, Bairati I, Samson E, et al.      IV +        Prognosis study, cohort of    •    Pts randomised to either         Mean wt loss 2.2kg                                           Results on early stage disease
Predictors of weight loss during              prognosis   a phase 3                          vitamin E/beta carotene or                                                                    only.
radiotherapy in patients with stage I or II               chemoprevention trial,             placebo.                         Factors associated with wt loss – all sites except larynx,
                                                          Canada                        •    Baseline characteristics and     higher pre RT body wt, stage II, dysphagia/odynophagia
head and neck cancer. Cancer
                                                                                             weight before and after RT.      pre RT, lower KPS.
2010;116:2275-83.                                         N=540
                                                                                        Outcomes:
                                                          Stage I or II head and neck   wt
                                                          cancer patients receiving
                                                          radiotherapy.
Citation                                       Level &   Study Design & Sample         Intervention & Outcomes                   Results                                                      Comments
                                               Quality
Nugent B, Lewis S, O'Sullivan JM. Enteral      IØ        Systematic review             Outcomes:                                 No conclusive evidence on which to base                      Given neutral rating due to
feeding methods for nutritional management                                             Change in or maintenance of the           recommendations for the optimal method of enteral            the fact only 1 article
in patients with head and neck cancers being             N=1                           nutritional status of the patient         feeding during treatment and in the post-treatment           included and this was of low
                                                                                       (measured by % BW difference              period – more research is required in this field.            quality.
treated with radiotherapy and/or
                                                         RCTs comparing one            and/or anthropometry measurement
chemotherapy. Cochrane Database of                       method of enteral feeding     changes e.g. triceps skin folds, mid      Further trials of the two methods of enteral feeding,
Systematic Reviews 2010; 17(3):CD007904.                 with another in adults with   arm muscle circumference, hand grip       incorporating larger sample sizes are needed.
                                                         H&N cancer receiving          strength difference) during and post
                                                         radiotherapy and/or           treatment period.
                                                         chemoradiotherapy.             • Complications arising from
                                                                                            enteral feeding device (infection,
                                                                                            tolerance of feeding device,
                                                                                            death).
                                                                                        • Time enteral feeding device
                                                                                            placed in relation to treatment
                                                                                            delivered.
                                                                                        • QoL, health economics, user
                                                                                            satisfaction of feeding device.
                                                                                        • Treatment breaks/gaps during
                                                                                            RT, prolongation of RT, non-
                                                                                            completion of RT.
                                                                                        • Length of time enteral feeding
                                                                                            required.
                                                                                        • Reason for discontinuation of
                                                                                            enteral feeding.


Nugent B, Parker MJ, McIntyre IA.              IV Ø      Retrospective Case series,    Aims:                                     TF required:                                                 Consultant decision on type
Nasogastric tube feeding and percutaneous                UK                            1. How different treatment                 1. Induction = 71%                                          of tube.
endoscopic gastrostomy tube feeding in                                                    modalities impact on need for           2. CCRT = 66%
                                                         N=196                            tube feeding.                           3. RT n=12%                                                 No statistical results
patients with head and neck cancer. J Hum
                                                                                       2. How the method of tube feeding                                                                      presented.
Nutr Diet 2010;23:277-84.                                H&N cancer patients              affects outcomes – wt, treatment       Mean %wt loss at end of treatment:
                                                         treated with radical             interruptions.                          1. Induction = -5.7%
                                                         radiotherapy, with or                                                    2. CCRT = -6.7%
                                                         without chemotherapy.         Included only patients who were seen       3. RT -3%
                                                                                       by dietitian within 1st week of
                                                         Groups:                       treatment. TF commenced when oral         Pts with a Pro Peg lost least weight compared to others
                                                         1. Induction chemo +          intake <60% and/or wt loss >5%.           (treatment PEG, NG or oral). Reported this was not
                                                             CCRT n=24                                                           statistically significant (no values).
                                                         2. CCRT n=76                  Outcomes: wt, treatment
                                                         3. RT alone n=96              interruptions                             Baseline wt loss prior to treatment, not different between
                                                                                                                                 groups (18-25%). Pts who had pre treatment weight loss
                                                                                                                                 and received dual modality treatment were more likely
                                                                                                                                 to have TF.

                                                                                                                                 Pts with oropharyngeal cancer had most wt loss (-6%).

                                                                                                                                 Limited treatment interruptions – method of feeding had
                                                                                                                                 no effect:
                                                                                                                                  1. Induction 8%
                                                                                                                                  2. CCRT = 7.9%
                                                                                                                                  3. RT = 5.2%
Citation                                        Level &   Study Design & Sample       Intervention & Outcomes                  Results                                                     Comments
                                                Quality
Oates JE, Clark JR, Read J, et al.              IV +      Prospective cohort,         Outcomes:                                Median weight loss during chemo 8.2 kg (2.3-13.9 kg)
Prospective evaluation of quality of life and             Australia                   • QOL                                    4-17%.
nutrition before and after treatment for                                              • Toxic effects (CTCAE)
                                                          N=14                                                                 N=13 required gastrostomy tube during treatment. N=12
nasopharyngeal carcinoma. Arch
                                                                                      Measured at pre-treatment, 3, 6, 12      removed by 6 months, n=1 tube feeding at 2yr.
Otolaryngol Head Neck Surg 2007;133:533-                  Nasopharyngeal cancer       and 24 months.
40.                                                       patients undergoing CRT                                              Deterioration in global health status in initial 3 months
                                                                                                                               and did not recover at 2 years p=.01

                                                                                                                               Reduced QOL for:
                                                                                                                               Fatigue P=0.01
                                                                                                                               Appetite loss P<0.001
                                                                                                                               Dysphagia P=.0.002
                                                                                                                               Sense problems P=0.03
                                                                                                                               Social eating P=0.005
                                                                                                                               Dental issues P=0.045
                                                                                                                               Trismus P=0.001
                                                                                                                               Xerostomia P<0.001
                                                                                                                               Sticky saliva P=0.001
                                                                                                                               Cough P=0.02
                                                                                                                               Feeling ill P=0.03

                                                                                                                               Improvements in QOL from baseline for:
                                                                                                                               Pain p=0.004
                                                                                                                               Emotional functioning p<0.001


Ogama N, Suzuki S, Umeshita K, et al.           IV Ø      117 patients receiving      Purpose: To investigate the              At 20Gy of radiation, appetite was affected by Brinkman
Appetite and adverse effects associated with              radiation therapy for H+N   relationship between radiation           index value, age and sensitivity to taste.
radiation therapy in patients with head and               cancer were investigated    treatment and adverse effects
                                                          for daily fluctuations in   resulting in changes in appetite.        At 30Gy of radiation, appetite was affected by frequency
neck cancer. European Journal of Oncology
                                                          saliva production,                                                   of oral care, xerostomia symptoms, age, sensitivity to
Nursing 2010;14:3-10.                                     analgesic use, frequency                                             taste, and oral mucositis.
                                                          of oral care, subject
                                                          characteristics and                                                  At 50Gy of radiation, appetite was affected by low saliva
                                                          appetite.                                                            production in the morning, frequency of oral care,
                                                                                                                               xerostomia symptoms, sensitivity to taste, analgesic use
                                                                                                                               and oral mucositis.

Ogama N, Suzuki S, Yasui Y, Azenishi K,         IV -      208 patients at two         Participants completed a                 For 30 Gy, a path was established using the four
Shimizu Y. Analysis of causal models of                   radiation doses, 30/50 Gy   questionnaire that comprised 48          intervening variables “ease of consuming foods in
diet for patients with head and neck cancer               completed a questionnaire   questions regarding dietary              smooth forms”, “ease of consuming foods with a
                                                          to investigate the impact   preferences, ease of consuming meals     chewable texture and suitable temperature”, “ease of
receiving radiation therapy. European
                                                          of radiotherapy on          based on food characteristics, overall   consuming lightly seasoned foods with a flavourful
Journal of Oncology Nursing 2010;14:291-                  appetite. Structural        ease of consuming a given meal,          smell” and “overall ease of consuming a given meal”
8.                                                        equation modeling was       change in ease of consumption based      from the relationship between “dietary preferences” and
                                                          used to define.             on the time of day and maintenance       “maintaining appetite while caring for the oral cavity”.
                                                                                      of appetite.
                                                                                                                               For 50 Gy, a path was established between “ease of
                                                                                      Structural equation modeling was         consuming foods that dissolve well in the mouth”, “ease
                                                                                      completed to express causes.             of consuming foods with a mild taste”, and “overall ease
                                                                                                                               of consuming a given meal”.
Citation                                         Level &   Study Design & Sample        Intervention & Outcomes                     Results                                                   Comments
                                                 Quality
Ouwens M. impact of an integrated care           III-3 Ø   Comparative study,           ICP covered 3 dimensions of                 •   Positive impact on number of outcomes such as         •   There are limitations
program for patients with head and neck                    Netherlands                  multidisciplinary patient care (Pt-             reduced waiting times, increased support for              such as little detail on
cancer on the quality of care. Head and                                                 oriented quality, Organisational                smoking cessation, assessment of scans by expert          each intervention (e.g.
                                                           N=311                        quality, Medical-technical quality) –           radiologist, and more nurse contact.                      type of nutrition support
Neck 2009;31:902-10.
                                                                                        including dietitian monitoring of           •   Number of pts seen by dietitian improved by 44%           etc).
                                                           2 cohorts of head and neck   weight and nutrition before, during             overall – pre ICP 0/147 seen, post ICP 61/139 seen,   •   Results dependent on the
                                                           cancer patients before       and after treatment following Dutch             (82% improvement in the sub group).                       workforce resources
                                                           (n=158) and after (n=153)    guidelines (although with limited           •   The program did not have any relevant effects on          available.
                                                           implementation of the        resources this was provided to oral             patient QoL or patient satisfaction.
                                                           integrated care program      cavity and oropharynx patients only).
                                                           (ICP).                       Outcomes:
                                                                                        1) Pt-oriented quality information
                                                                                               supply; emotional and social
                                                                                               support; support for cessation of
                                                                                               smoking and EtOH
                                                                                               consumption.
                                                                                        2) Organisational quality (waiting
                                                                                               and throughput times and
                                                                                               continuity of care).
                                                                                        3) Medical-technical quality
                                                                                               (speech & swallowing
                                                                                               revalidation, nutritional support,
                                                                                               assessment of CT & MRI
                                                                                               procedures, dental
                                                                                               consultation).
                                                                                        4) Other outcome indicators: QoL
                                                                                               in general; QoL for pts with
                                                                                               HNC and pt satisfaction.
Paccagnella A, Morello M, Da Mosto MC,           III-3 Ø   Retrospective cohort         Intervention:                               NG vs. CG:                                                •   Early nutrition
et al. Early nutritional intervention improves             Italy                        Retrospective audit of pts seen Pre-        Lost less wt (-4.6+4.1% vs. -8.1+4.8%) of pre-Rx wt           intervention in HNC pts
treatment tolerance and outcomes in head                                                CRT comparing groups before and             (p<0.01).                                                     undergoing CRT resulted
                                                           NG n=33                      after implementation of an                  Fewer RT breaks (>5d) for toxicity (30.3% vs. 63.3%),         in improved treatment
and neck cancer patients undergoing
                                                           CG n=33                      institutional early nutrition support       (p<0.01).                                                     tolerance and fewer
concurrent chemoradiotherapy. Support                                                   program.                                    Mean no. days RT delay for toxicity 4.4 + 5.2 vs. 7.6         hospital admissions.
Care Cancer 2010;18:837-45.                                Diff between groups at       Early Nutrition Intervention Group          +6.5, (p<0.05).                                           •   NB above has important
                                                           baseline - more with         (NG) vs. Control group (CG).                Linear correlation between % wt loss from baseline to         financial and economic
                                                           history of smoking/EtOH      Outcomes:                                   CRT completion and days of radiation delay (p<0.01).          implications.
                                                           in CG not significant but?    • Weight change from baseline              Less unplanned hospital admission (16.1% vs. 41.4%),      •   Suggests nutrition
                                                           Type II error 2° small             (V0) @ wk 4 (V1), end CRT             (p<0.03).                                                     intervention must be
                                                           sample size.                       (V2), 1/12(V3), 3/12 (V4) and         60.6% NG pts needed tube feeding.                             initiated prior to CRT
                                                                                              6/12 (V5) post.                                                                                     and needs to continue
                                                           HNC pts undergoing            • No. of RT # delayed for toxicity         Overall PG-SGA:                                               after Rx completion.
                                                           curative CRT (Stage II-       • No. of unplanned hospital                V0 27.3% malnourished (PG-SGA B or C)
                                                           IV), oropharynx,                   admissions for mucositis.             V1 75.8%
                                                           hypopharynx,                  • Presence of symptoms                     V2 34.8%
                                                           nasopharynx, larynx, oral          influencing nutritional status        V2 64.3%
                                                           cavity, paranasal sinus,           (loss of appetite, nausea,            V4 39.4%
                                                           parotid).                          vomiting, dysphagia,                  V5 24.3%
                                                                                              xerostomia, taste).
                                                                                         • Nutritional status over treatment        Conclusion:
                                                                                              period and up to 6/12 post.           Early nutrition intervention in HNC pts undergoing CRT
                                                                                         • Nutritional intake (diet history,        resulted in improved treatment tolerance and fewer
                                                                                              24 h recalls).                        hospital admissions.
                                                                                         • PG-SGA
Citation                                           Level &   Study Design & Sample         Intervention & Outcomes                 Results                                                     Comments
                                                   Quality
Patil PM, Warad NM, Patil RN, Kotrashetti          IV Ø      Case series, India            Outcomes:                               Duration:
SM. Cervical pharyngostomy: an alternative                                                 • Complications                         Feeding time 31 – 230 days (average 92.4 days).
approach to enteral feeding. Oral Surg Oral                  N=15                          • Length of time tube remained in       N=4 maintained the tube during RT.
Med Oral Pathol Oral Radiol Endod                                                              situ
                                                             Patients treated surgically                                           Complications:
2006;102:736-40.                                             for oropharyngeal                                                     • Accidental removal n=1
                                                             malignancy and who were                                               • Reflux oesophagitis and kinking of the tube n=1
                                                             fed through a                                                         • Hyperemia around the stoma n=1
                                                             pharyngostomy.

Pauloski BR, Rademaker AW, Logemann                IV Ø      Cohort of patients at         Intervention:                           • Extent of mucositis score (EMS) demonstrated a            • The change in oral
JA, et al. Relation of mucous membrane                       different stage of disease,   49 (82%) received chemoRTx,               significant linear decrease over time (mean regression      mucositis and pain over
alterations to oral intake during the first year             USA                           5 (8%) had primary surgical               coefficient =-0.09; p = .001).                              time, although statistically
                                                                                           intervention followed by chemoRTx,      • All the functional measures of eating (PSSD, PSSE,          significant, was probably
after treatment for head and neck cancer.
                                                             N=60 (no nutritional          and 6 (10%) had surgery with              percent of oral intake) demonstrated significant linear     not clinically significant
Head & Neck 2010;33:774-9.                                   status or anthropometrics     postoperative RTx.                                                                                    given the small degree of
                                                                                                                                     increases over time, indicating an improvement in
                                                             given).                                                                 function. PSSD (performance status scale for H&N            mucositis ratings and very
                                                                                           Average radiation dose to the primary     Ca diet scale) had a mean regression coefficient of         low ratings of pain.
                                                             30 (50%) had tumors in        of 6896 cGy. 54 patients received         4.75 (p < .0001), PSSE (performance status scale for      • Although this study
                                                             the oropharynx, 12 (20%)      some form of chemo (included              H&N Ca public eating scale) had a mean regression           investigated the
                                                             laryngeal, 4 (7%) oral        cisplatin, carboplatin, paclitaxel,       coefficient of 2.97 (p = .015), and percent of oral         relationships between
                                                             cavity; 3 (5%)                and 5-fluorouracil).                      intake had a mean regression coefficient of 5.58            chronic oral mucosal
                                                             hypopharynx. 6 (10%)                                                    (p = .0001).                                                changes and functional
                                                             nasopharynx and 5 (8%)        Outcomes:                               • Decreases in the mucositis scales over time are             measures of eating and
                                                             presented with an              • 1, 2, 3, 4, 6, and 12 months           associated with increases in the PSSD scale over time.      swallowing, correlation
                                                             unknown primary.                  post–cancer treatment                 Changes in all mucositis scores except EMS were             does not indicate
                                                             (62%) had stage IV                completion.                           correlated significantly negatively with changes in         causation.
                                                             disease, 12 (20%) stage III    • Weight of stimulated saliva.           percent of nutrition taken orally.                        • It may well be, therefore,
                                                             disease, 7 (12%) stage II,     • Ratings of oral mucositis            • Decreases in the mucositis scales over time were            that long-term changes in
                                                             and 4 (7%) stage I disease.       (OMAS scale).                         associated with increases in the oral intake scale over     oral mucosa after
                                                                                            • Patients rating of oral pain.          time.                                                       treatment for cancer of the
                                                                                            • % of nutrition taken orally          • No variable was significantly correlated with change        head and neck co-
                                                                                               (patient estimate).                   in pain or change in saliva weight.                         occurred with a reduction
                                                                                            • Performance status scale for                                                                       in functional swallow
                                                                                               patients with H&N Ca.                                                                             measures but did not
                                                                                                                                                                                                 cause the functional
                                                                                                                                                                                                 impairment.

Pauloski BR, Rademaker AW, Logemann                IV Ø      Case series, multicentre,     Outcomes:                               Motility Disorders related to Oral Intake:                  •   No nutritional status
JA, et al. Relationship between swallow                      USA                           • Swallowing - MBS                      <50% Oral intake at evaluation point:                           data.
motility disorders on videofluorography and                                                • Nutrition – texture, intake           • Before cancer treatment: 5.1%                             •   Patient reported criteria
                                                             N=170                                                                                                                                 for <50% or > 50%
oral intake in patients treated for head and                                                                                       • 1 month: 39.5%
                                                                                           Evaluation points:                                                                                      intake which could
neck cancer with radiotherapy with or                        Head and neck cancer                                                  • 3 month: 25.9%
                                                                                           • Before cancer treatment with RT                                                                       increase bias and not
without chemotherapy. Head Neck                              patients treated with                                                 • 6 month: 19%
                                                                                               with or without chemo                                                                               reflect accurately the %
2006;28:1069-76.                                             radiotherapy with or                                                  • 12 months: 12.5%                                              oral v enteral nutrition.
                                                                                           • 1 month
                                                             without chemotherapy.         • 3 month                               <50% by site of lesion greatest in the following            •   Selection criteria for tube
                                                                                           • 6 month                               compared to other tumour sites:                                 placement not
                                                                                           • 12 months                             • Oral cavity: 15.4% (1), 57.1% (2), 42.9% (3), 40.0%           mentioned.
                                                                                                                                      (4), 33.3% (5)                                           •   Variable participant
                                                                                                                                   • Oropharyngeal: 8.2% (1), 43.9%(2), 33.9 (3), 19.1%            numbers at each time
                                                                                                                                      (4), 12.9% (5)                                               point.
Citation                                      Level &   Study Design & Sample          Intervention & Outcomes                  Results                                                        Comments
                                              Quality
                                                                                                                                Motility Disorders related to non normal diet:
                                                                                                                                Non normal diet at evaluation point:
                                                                                                                                • Before cancer treatment: 37.8%
                                                                                                                                • 1 month: 74.4%
                                                                                                                                • 3 month: 63.6%
                                                                                                                                • 6 month: 56%
                                                                                                                                • 12 months: 40.3%
                                                                                                                                Non normal diet by site of lesion greatest in the
                                                                                                                                following compared to other tumour sites:
                                                                                                                                • Oral cavity
                                                                                                                                Non normal diet at each evaluation point:
                                                                                                                                • All groups at 1 month post treatment with a
                                                                                                                                   reduction at 12 months post treatment

Pesola GE, Hogg JE, Yonnios T, McConnell      III-2 Ø   Comparative cohort with        All groups NBM and fed to target of      No difference between groups for bowel movement
RE, Carlon GC. Isotonic nasogastric tube                concurrent control, USA        30kcal/kg/d.                             frequency NS.
feedings: do they cause diarrhea? Crit Care
                                                        N=29                           Healthy n=5                              Albumin levels lower in ICU pts compared to H&N and
Med 1989;17:1151-5.
                                                                                       (Fed with gravity drip via NGT for 2     controls p<0.05.
                                                        Identified 2 cohorts of        days).
                                                        patients routinely enterally
                                                        fed at hospital.               H&N pts n=13
                                                                                       (Fed day 1 post op with 5 bolus
                                                                                       feeds/day given via gravity).

                                                                                       ICU pts n= 11
                                                                                       (Commenced NGT within 4 days of
                                                                                       admission and fed via pump).

                                                                                       Outcomes: Albumin, bowels.

Pezner RD, Archambeau JO, Lipsett JA,         III-2 Ø   Comparative cohort study       TF by NG, cervical oesophagostomy        % wt loss during RT                                               TF timing and type based
Kokal WA, Thayer W, Hill LR. Tube                                                      or gastrostomy route.                         PTF = 4.8%                                                   on individual physician
feeding enteral nutritional support in                  N=89                                                                         ITF = 9.4%                                                   preference and pt
                                                                                       1. Planned TF (n=17): NG = 4,                 No TF = 7.1%                                                 acceptance.
patients receiving radiation therapy for
                                                        Patients undergoing            cervical oesophagostomy = 4,             % pts >10% wt loss                                                Malnourished at
advanced head and neck cancer. Int J Radiat             curative RT for Stage III      gastrostomy = 9. Started before RT.           PTF = 6%                                                     presentation – more
Oncol Biol Phys 1987;13:935-9.                          or IV SCC of                   2. Interventional TF (n=9): NG = 3,           ITF = 44%                                                    likely to get planned TF.
                                                        nasopharynx, oropharynx,       gastrostomy n=6.                              No TF = 24%                                                  Note this is an old study
                                                        hypopharynx and larynx.        3. No TF (n=63)                          Wt loss was greater in those patients not initially               using pt data and older
                                                                                                                                malnourished (14/46 i.e. 30% in No TF group and 1/7               RT technology from up
                                                                                       Pts did not receive ITF until they had   i.e. 14% in planned TF group; however not statistically           to 32 years ago∴?
                                                                                       lost weight during RT (10-71d after      significant due to small numbers). Few malnourished               Relevance with respect
                                                                                       start of RT).                            pts lost >10% of initial wt during RT.                            to current practice and
                                                                                                                                Failure to complete at least 90% RT dose and/or need for          treatment regimes.
                                                                                       Outcomes:                                Rx break >10d occurred in 30% no TF group, 22% Int
                                                                                       % weight loss (pre and post RT).         TF and 24% planned TF.
                                                                                                                                7/26 (27%) pts had complications due to tube feeding
                                                                                                                                (gastric ulcer – 3; gastritis – 1; aspiration pneumonia - 1;
                                                                                                                                cerv. Oesoph. Stoma ulcer – 1; hepatic enceph 2° protein
                                                                                                                                intake – 1).
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes                Results                                                      Comments
                                              Quality
Picker H, Bichler E. Nutritional and          IV -      Prospective cohort,         Nutrition and immune parameters        At baseline, n=3 were malnourished.                          Poorly written paper –
immunological investigations in head and                Austria                     measured at baseline, after chemo,                                                                  minimal details/ discussion.
neck cancer patients before and after                                               after surgery and after RT.            At baseline immune function was in lower end of
                                                        N=20                                                               healthy range.
therapy. Arch Otorhinolaryngol
                                                                                    Outcomes:
1985;242:149-53.                                        H&N cancer receiving        Nutrition: wt, TSF, MAC,               Nutrition and immune parameters declined after chemo
                                                        neoadjuvant                 prealbumin, albumin, other lab         and did not improve until the end of primary treatment.
                                                        chemotherapy, followed      values.
                                                        by surgery and RT.

                                                        Plus 20 healthy age
                                                        matched controls for
                                                        immune measures.
Piquet M-A, Ozsahin M, Larpin I, et al.       III-3 +   Cohort with historical      N=45 ambulatory patients               Complications of PEG: minor (site infection, leakage,        Groups similar wrt age and
Early nutritional intervention in                       control.                    undergoing XRT for oropharyngeal       abdo pain): 21%; major (site infection requiring             TNM staging.
oropharyngeal cancer patients undergoing                                            Ca: early, systematic PEG insertion.   admission): 2%.
                                                                                    PEG n = 33 (74%) versus n= 5 (11%)                                                                  Did not measure QOL but
radiotherapy. Support Care Cancer
                                                                                    in historical control group.           8% controls required hospital admission for dehydration      assumed that QOL is better
2002;10:502-4.                                                                                                             vs. 0 in intervention group (p<0.01).                        for PEG pts.
                                                                                    PEG insertion based on criteria
                                                                                    Indications for pre-Rx PEG = wt loss   Significantly less wt loss in intervention group 3.5 + 0.7
                                                                                    >10%, BMI< 20, age >70. n=33           vs. 6.1+ 0.7. (p<0.01).
                                                                                    (74%).

                                                                                    Those without PEG’s (n=12)
                                                                                    received counseling and supplements.

                                                                                    N/g required in 6/12 (50%) of the
                                                                                    comparison group during XRT.
Platek ME, Reid ME, Wilding GE, et al.        III-3 Ø   Retrospective cohort        Intervention: IMRT and CCRT            15 of 78 patients experienced locoregional failure.          Pre-treatment %IBW is
Pretreatment nutritional status and                     study, United States                                               In the locoregional failure group:                           associated with locoregional
locoregional failure of patients with head                                          Outcomes:                              More patients below normal IBW pre-treatment in              failure of H&N cancer
                                                        Locoregional failure n=15   Locoregional failure                   locoregional failure group than w/out locoregional           following CCRT.
and neck cancer undergoing definitive
                                                        Non locoregional failure    %IBW, %weight change, treatment        failure (p= 0.01).
concurrent chemoradiation therapy. Head &               n=63                        duration, serum albumin, serum         Compared with pts whose %IBW was normal pre-
Neck 2010;15:15.                                                                    haemoglobin.                           treatment, pts whose %IBW was below normal had a 4-
                                                        T1-T4 SCC of larynx,                                               fold risk of locoregional failure in a model that
                                                        oropharynx, or                                                     controlled for treatment duration & pre-treatment Hb
                                                        hypopharynx and                                                    (p= 0.04).
                                                        underwent IMRT and                                                 No significant differences for haemoglobin or serum
                                                        CCRT.                                                              albumin on multivariate analysis.

Poulsen MG, Riddle B, Keller J, Porceddu      IV Ø      Post hoc analysis of        Pts randomised to:                         Treatment field lengths >82mm for the second phase           Lack of nutrition
SV, Tripcony L. Predictors of acute grade 4             multicentre RCT,               1. Conventional RT                      of RT increased the probability of requiring                 outcome data.
swallowing toxicity in patients with stages             Australia & New Zealand        2. Accelerated RT                       intervention with PEG or NGT.                                Applications in the
                                                                                                                               Probability of Grade 4 swallowing was 36% if the             IMRT/conformal RT era
III and IV squamous carcinoma of the head
                                                        N= 343                      Outcomes:                                  phase 2 treatment length was >82mm vs. 16% for               (all planning in this study
and neck treated with radiotherapy alone.                                           Grade IV swallowing toxicity               <82mm (p=0.0001). Hazard Ration 2.4 (95%CI 1.6,              was 2-D and largely
Radiother Oncol 2008;87:253-9.                          Stage III or IV Invasive    Time to swallowing toxicity                3.7).                                                        involved opposed lateral
                                                        SCC (oral cavity;                                                                                                                   fields hence greater
                                                        oropharynx; hypopharynx     Swallowing Function Ax time points:                                                                     volume of pharynx
                                                        or larynx) receiving        baseline, weekly for 12 wks then                                                                        treated).
                                                        curative RT                 monthly until 24 weeks.                                                                                 Effect of concurrent
                                                                                                                                                                                            chemotherapy.
Citation                                     Level &   Study Design & Sample        Intervention & Outcomes                Results                                                   Comments
                                             Quality
Prasad KC, Sreedharan S, Dannana NK,         III-2 Ø   Prospective concurrent       Intervention group (n=40) – early      Fistula rates:                                            No statistics
Prasad SC, Chandra S. Early oral feeds in              cohort study, India          oral feeding - commenced day 2 post    Early: n=1 Late: n=2
laryngectomized patients. Ann Otol Rhinol                                           op. Clear fluids for 2 days. Free
                                                       N=78                         fluids for 2 days. Then soft diet.     LOS <10days:
Laryngol 2006;115:433-8.
                                                                                                                           Early: 75% Late: 37%
                                                       Patients with ca larynx      Control group (n=38) – late oral
                                                       undergoing laryngectomy.     feeding - commenced day 10 post op.

                                                                                    Outcomes: (at day 2 & day 10 post
                                                                                    op)
                                                                                    • Fistulas
                                                                                    • LOS



Rabinovitch R, Grant B, Berkey BA, et al.    IV Ø      Post hoc analysis of         Unplanned secondary analysis of a      Weight loss:                                              Imbalance of poorer
Impact of nutrition support on treatment               multicentre RCT, USA         phase III prospective RCT on 4            •      Significantly less weight loss by end of        prognostic features at
outcome in patients with locally advanced                                           definitive XRT fractionation                     treatment in those receiving BNS (median 5%     baseline/pre-treatment (that
                                                       N=1073                       schedules.                                       vs. 7%, p=0.0001)                               could possibly affect
head and neck squamous cell cancer treated
                                                                                                                                                                                     outcomes) however these
with definitive radiotherapy: a secondary                                                                                  Mucositis:
                                                       Untreated Stage III or IV,   Outcomes:                                                                                        were taken into account in
analysis of RTOG trial 90-03. Head Neck                                                                                      •        Trend towards lower incidence of grade 3-4
                                                       M0 SCC or oral cavity,       • Type and timing of NS used                                                                     analyses.
2006;28:287-96.                                                                                                                       mucositis after treatment in those receiving
                                                       oropharynx, supraglottic         (BNS = baseline nutrition
                                                                                                                                      BNS (100/293:34% vs. 311/780:40%)
                                                       larynx, Stage III-IV             support)                                                                                     The analysis of NS and
                                                       carcinoma of base of         • Weight loss                          Locoregional control:                                     cancer outcome was not
                                                       tongue or hypopharynx.       • Mucositis                               •     Poorer in patients receiving BNS compared        designated as an up-front
                                                                                    • Dysphagia                                     with TNS or no NS (29%, 55%, 57%                 endpoint in this study, and
                                                                                    • Treatment outcomes: treatment                 respectively)                                    the collected NS information
                                                                                        breaks, Elapsed days of               •     No NS vs TNS (p=0.53), TNS vs BNS                is quite limited.
                                                                                        treatment, Locoregional control,            (p<0.0001), no NS vs BNS (p<0.0001)
                                                                                        Overall survival                   Overall Survival:
                                                                                                                              •      Poorer in patients receiving BNS compared
                                                                                    Time points:                                     with TNS or no NS (16%, 36%, 49%
                                                                                    Pre-treatment, at completion of                  respectively)
                                                                                    treatment, 3 months and 6 months          •      No NS vs TNS (p=0.011), TNS vs BNS
                                                                                    post treatment completion.                       (p<0.0001), no NS vs BNS (p<0.0001)
                                                                                                                           Treatment:
                                                                                                                              •     Patients receiving BNS were no less likely to
                                                                                                                                    receive total prescribed radiation dose than
                                                                                                                                    other patients (71.5Gy vs. 72.6Gy: p=0.14)
                                                                                                                              •     Those with BNS completed treatment within
                                                                                                                                    same time frame as other patients

                                                                                                                           After stratifying for known prognostic variables – BNS
                                                                                                                           found to be highly significant for increased risk of
                                                                                                                           locoregional failure (HR: 1.47:95% CI, 1.21-1.79:
                                                                                                                           p<0.0001) and death (HR: 1.41;95% CI, 1.19-
                                                                                                                           1.67;p<0.0001).
Citation                                        Level &   Study Design & Sample      Intervention & Outcomes                 Results                                                       Comments
                                                Quality
Rademaker AW, Vonesh EF, Logemann JA,           IV Ø      Multicentre case series,   Data on the ability to eat was          Gastric tubes in place:                                       High attrition 64% but
et al. Eating ability in head and neck cancer             USA                        obtained at 5 time points: pre-           • Pre-treatment-12%, 1 month-48%, 3 months-36%,             counted all in the analysis.
patients after treatment with                                                        treatment and 1, 3, 6 and 12 months            6 months-24%, 12 months-14%.
                                                          N=255                      post completion of chemoradiation,        • No differences in age, gender and presence of
chemoradiation: a 12-month follow-up study
                                                                                     and then analysed taking into account          stage IV disease according to length of follow up.
accounting for dropout. Head Neck                         H&N cancer to be treated   dropout.                                  • There were more oropharyngeal lesions in patients
2003;25:1034-41.                                          with RT + chemo.                                                          who remained in the study the longest (p=0.03).
                                                                                     Outcomes:                                 • Mean radiation dose was lowest in the group
                                                                                     • % of patients who could eat no               observed only at baseline (7 of these did not
                                                                                         more than 50% of their diet                receive any radiation treatment) (p=0.0001).
                                                                                         orally                              Oral intake decreased sharply immediately after
                                                                                     • % of patients who could not eat       chemoradiation and improved to near baseline levels
                                                                                         a normal diet                       after 12 months of follow up:
                                                                                                                               • % of patients with <50% of oral intake : 7% pre
                                                                                                                                    treatment, 39% at 1 month post, 25% at 3 months,
                                                                                                                                    11% at 12 months post treatment.
                                                                                                                               • GEE analyses provided similar percentages over
                                                                                                                                    time, with all time points having a significantly
                                                                                                                                    greater % than baseline.
                                                                                                                               • Ridout’s test: dropout significantly related to a
                                                                                                                                    lower oral intake at the visit before dropout
                                                                                                                                    (p=0.004).
                                                                                                                               • For GEE, CLM, SPM: p<0.001 for differences
                                                                                                                                    across all evaluations, p<0.0001 comparing pre-
                                                                                                                                    treatment with each 1, 3, 6 months post treatment.
                                                                                                                                    Comparing pre-treatment with 12 months: p=0.007
                                                                                                                                    for GEE, p<0.001 for CLM, p=0.001 for SPM.
                                                                                                                               • Weight reduced from baseline to post-treatment
                                                                                                                                    time points (weight was not a significant factor –
                                                                                                                                    after adjusting for other covariates, weight was not
                                                                                                                                    related to oral intake).
                                                                                                                               • % of patients who could not eat a normal diet (%
                                                                                                                                    of patients who could not eat all food
                                                                                                                                    consistencies): 44% at pre-treatment, Rises
                                                                                                                                    sharply to 78% at 1 month post, 66% at 3 months,
                                                                                                                                    44% at 12 months post treatment.
                                                                                                                               • GEE analyses provided similar estimated %’s (all
                                                                                                                                    time points having significantly greater %’s than
                                                                                                                                    baseline except for 12 months).
                                                                                                                               • Ridout’s test: dropout significantly related to
                                                                                                                                    occurrence of a non-normal diet at the visit before
                                                                                                                                    dropout (p=0.03).
                                                                                                                               • For GEE, CLM, SPM analyses: p<0.001 for
                                                                                                                                    differences across all evaluations, p<0.001
                                                                                                                                    comparing pre-treatment with each of 1, 3, 6
                                                                                                                                    months post treatment. Comparing pre-treatment
                                                                                                                                    with 12 months, p=0.24 for GEE, p=0.10 for CM,
                                                                                                                                    p=0.09 for SPM.
                                                                                                                             Food consistencies:
                                                                                                                               • Liquids easiest to eat
                                                                                                                               • Thick liquids, pudding, soft foods – similar levels
                                                                                                                                    of dysfunction over time
                                                                                                                               • Crunchy textures most difficult
Citation                                      Level &   Study Design & Sample        Intervention & Outcomes                    Results                                                      Comments
                                              Quality
Ravasco P, Monteiro-Grillo I, Camilo ME.      IV Ø      Case series, Portugal        Outcomes of nutritional counselling        Nutritional status:                                          Most results combined with
Does nutrition influence quality of life in                                          initiated prior to RT: data collected         Before RT:                                                other tumour groups (No
cancer patients undergoing radiotherapy?                N=125                        prospectively on QoL and nutritional            - Malnourished: all patients with stomach cancer,       individual p values for H&N
                                                                                     parameters and associations and                    52% of HN patients, 13% of CR patients               data).
Radiother Oncol 2003;67:213-20.
                                                        Cancer patients              correlations determined. Patients               - Well nourished: in HR group only 1 patient with
                                                        undergoing radiotherapy -    were grouped as either high risk or                OES, 13% of CR patients were obese
                                                        primary, adjunctive to       low risk according to tumour site.            Severe malnutrition was never seen in LR patients.
                                                        surgery or with palliative                                                 Either at onset or end of RT, malnutrition
                                                        intent.                      Intervention:                                 (moderate+severe) was more often present in FR
                                                                                     Individualised dietary advice based           group (p=0.02).
                                                                                     on current foodstuffs (neither                Nutritional status remained stable in all but 1 HN
                                                                                     nutritional supplements nor enteral           patient (mod malnutrition deteriorated).
                                                                                     tube feeding were ever used).              Symptoms:
                                                                                                                                   Throughout RT, symptoms increased (anew / in
                                                                                     Time points:                                  severity) in HR group only (p=0.0001).
                                                                                     Assessment of nutrition status, food          The number of patients experiencing odynophagia
                                                                                     intake, dietary advice at onset, after 2      (xerostomia, mucositis, taste changes) increased
                                                                                     weeks and at the end of RT.                   from 4 to 20.
                                                                                     QoL evaluated at the onset and at the         Dysphagia increased from 1 patient to 19.
                                                                                     end of RT.                                    Anorexia increased from 9 to 15.
                                                                                                                                   Nausea increased from 3 to 13.
                                                                                     Outcomes:                                  Nutritional intake:
                                                                                     QoL, nutritional status, nutrient             Associated with nutritional status (p=0.007).
                                                                                     intake                                        Lower baseline energy intakes in HR group vs. LR
                                                                                                                                   (p=0.002).
                                                                                     GI tract (stage I-IV): OES(6), STO(5)         HN group: baseline median energy intakes were
                                                                                     – both 45Gy, CR(46) – 50Gy                    significantly lower than their EERs (p=0.01).
                                                                                     Head and neck (stage II-IV): BOT(3),          Median energy intakes increased (p<0.03 for HR
                                                                                     salivary gland(1), tonsil(2), NP(3),          group as a whole) and exceeded the median EER
                                                                                     oropharynx(3), larynx(11) – all 70-           during treatment despite symptom increase
                                                                                     74Gy.                                         (attributed by patients to the individualised nutrition
                                                                                                                                   counselling).
                                                                                     High risk (HN, GI tract) patients          QoL - EUROQOL dimensions:
                                                                                     (n=80) at pre treatment:                      All QoL dimensions always better in LR vs. HR
                                                                                         43 patients well nourished                patients (p=0.01).
                                                                                         30 patients moderately                    OES, STO and HN reported the worse QoL.
                                                                                         malnourished                              All QoL dimension scores (except pain/discomfort)
                                                                                         3 patients severely malnourished          did improve in spite of RT (p=0.004).
                                                                                                                                   Pain/discomfort worsened throughout RT in
                                                                                     Low risk patients (n=45) at pre               association with worsened anorexia (p=0.001),
                                                                                     treatment:                                    diarrhoea (p=0.002), dysphagia (p=0.01),
                                                                                          35 patients well nourished               odynophagia (p=0.04) nutritional intake still
                                                                                          10 patients moderately                   improved though.
                                                                                          malnourished                             Worse mobility was associated with malnutrition
                                                                                          No patients severely                     (p=0.01) or reduced energy intake (p=0.0).
                                                                                          malnourished                             Usual activities, anxiety/depression also associated
                                                                                                                                   with malnutrition and decreased energy intakes.
                                                                                     Prevalence of baseline malnutrition:          Multivariate: association between worse nutritional
                                                                                     HR vs. LR (p=0.02).                           status and worse mobility (p=0.03) or anxiety/
                                                                                                                                   depression (p=0.05).
                                                                                                                                   End of RT, QoL improvement in HR group was
                                                                                                                                   correlated with increased nutritional intake (r=0.78,
                                                                                                                                   p=0.001).
Citation                                       Level &   Study Design & Sample      Intervention & Outcomes                  Results                                                       Comments
                                               Quality
                                                                                                                             Self-rated Health Status (SRHS):
                                                                                                                                 Improved significantly in HR group (p=0.01).
                                                                                                                                 Baseline malnutrition was associated with lower
                                                                                                                                 SRHS (p=0.002).
                                                                                                                                 At end of RT improved nutritional status was
                                                                                                                                 associated with higher SRHS (p=0.03).
                                                                                                                                 Multivariate analysis at end of RT: only association
                                                                                                                                 with nutritional intake (p=0.001).
                                                                                                                             EORTC QLQ:
                                                                                                                                 Overall QoL pattern at both time points worse in HR
                                                                                                                                 patients (p=0.002).
                                                                                                                                 HR group at end of RT: improvements - function
                                                                                                                                 scales (p=0.001), deterioration - fatigue, pain
                                                                                                                                 (p=0.003), nausea/ vomiting (p=0.04), appetite
                                                                                                                                 (p=0.001).
                                                                                                                                 HR group at baseline: malnutrition was associated
                                                                                                                                 with worse function scales: global QoL (p=0.05) and
                                                                                                                                 with symptoms.
                                                                                                                                 Multivariate analyses: nutritional intake identified as
                                                                                                                                 the only variable associated with global QoL
                                                                                                                                 (p=0.001), physical, role, emotional functions.
                                                                                                                             Increase in each patients’ nutritional intake was
                                                                                                                             correlated with the increase of global QoL (r=0.78,
                                                                                                                             p=0.001).


Ravasco P, Monteiro-Grillo I, Vidal PM,        IV Ø      Case series, Portugal      HN=87, OES=14, STO=26, CR=144            Nutritional status:                                           Results are for 4 tumour
Camilo ME. Cancer: disease and nutrition                                                                                        Weight loss significantly higher in patients with          groups, however results show
are key determinants of patients' quality of             N=271                      Nutritional parameters, QoL and             Stage III/IV disease than I/II (p=0.001).                  individually for HN:
                                                                                    disease characteristics were collected      175/206 (85%) of Stage III/IV had wt loss >10%.            decreases in E/P intakes – no
life. Support Care Cancer 2004;12:246-52.
                                                         HN, OES, STO, CR           prior to radiotherapy planning.             Lower wt losses in HN+CR compared with                     individual p values.
                                                         cancer referred for                                                    OES+STO (p=0.04).
                                                         radiotherapy (included     Outcomes: QOL                                                                                          Reasonably good quality
                                                         primary, adjuvant to                                                QoL:                                                          study (apart from above
                                                         surgery, combined with     Nutritional status - % weight loss         E+P intakes were correlated with function scales and        issues), adjusts for stage of
                                                         chemo or with palliative   over the previous 6 months (>10% =         with some symptoms: Global QoL (r=0.53,                     disease and cancer location,
                                                         intent).                   severe).                                   p=0.001), physical (r=0.26, p=0.02), emotional              however cross-sectional
                                                                                                                               (r=0.29, p=0.01), anorexia (r=-0.52, p=0.001),              study (level IV) and p value
                                                                                                                               fatigue (r=-0.6, p=0.001), pain (r=-0.55, p=0.003),         results include 4 tumour
                                                                                                                               n+v (r=-0.51, p=0.003), diarrhoea (r=-0.6, p=0.001).        groups.
                                                                                                                               Malnutrition assoc with poorer function scales and
                                                                                                                               some symptoms (Global QoL, physical, role,                  Large numbers of CR
                                                                                                                               cognition, emotional, social, anorexia, fatigue,            (144/271).
                                                                                                                               dyspnoea, insomnia, diarrhoea.
                                                                                                                               Strong correlation between QoL and cancer stage
                                                                                                                               and nutrition status.
                                                                                                                               Functional capacity for all diagnoses significantly
                                                                                                                               influenced by current nutrition intake deficits and
                                                                                                                               recent weight loss (but was not affected by stage).
Citation                                     Level &   Study Design & Sample      Intervention & Outcomes                 Results                                                        Comments
                                             Quality
                                                                                                                          Nutrition intakes:
                                                                                                                              Stage III/IV: current protein intakes were
                                                                                                                              significantly lower than ref values (RVs) (p=0.001),
                                                                                                                              energy intakes were within EER.
                                                                                                                              Stage I/II: current E+P intakes significantly higher
                                                                                                                              than RVs and EERs (p=0.005).
                                                                                                                              Current intakes: all reduced compared with usual
                                                                                                                              intakes, all higher than EER and EPR except for P
                                                                                                                              intake for STO.
                                                                                                                              Current E+P intakes lower in Stage III/IV than Stage
                                                                                                                              I/II (p=0.0002 and p=0.001 respectively).
                                                                                                                              Largest decreases for E+P intakes: HN + OES stage
                                                                                                                              III/IV disease (p=0.02).
                                                                                                                              Stratified analysis: stage III/IV – significant decrease
                                                                                                                              from usual E+P intakes (p=0.001 and p=0.0002) in
                                                                                                                              contrast to stage I/II.
                                                                                                                          Effect sizes estimates:
                                                                                                                          Major determinants of QoL
                                                                                                                              Stage of disease (p=0.002)
                                                                                                                              Deterioration in nutritional status (p=0.005)
                                                                                                                              Dietary intake (p=0.007)
Ravasco P, Monteiro-Grillo I, Marques        II +      RCT, Portugal              Subjects stratified by cancer stage     Intakes:
Vidal P, Camilo ME. Impact of nutrition on                                        were randomised to the following        End of RT:
outcome: a prospective randomized                      N=75                       groups:                                 Significant increase in energy intakes at end of RT for
                                                                                    1. Dietary counselling with           group 1 (p=0.002) and for group 2 (p=0.05).
controlled trial in patients with head and
                                                       All consecutive,                  regular foods                    Group 1 had higher energy intake than group 2 at end of
neck cancer undergoing radiotherapy. Head              ambulatory patients with     2. Usual diet plus supplements        RT (p=0.005).
Neck 2005;27:659-68.                                   head and neck cancer who     3. Intake ad lib                      Significant increase in protein intakes at end of RT for
                                                       were referred for                                                  group 1 (p=0.006) and for group 2 (p=0.001).
                                                       radiotherapy - Primary,    Dietary counselling vs. supplements     Group 2 had higher protein intakes than group 1 at end
                                                       adjuvant to surgery,       vs. intake ad lib (Group 1: 25, Group   of RT (p=0.06).
                                                       combined with              2: 25, Group 3: 25).                    Significant decrease in energy and protein intakes at end
                                                       chemotherapy or                                                    of RT for group 3 (p<0.01).
                                                       administered with          Outcomes:                               3 months post:
                                                       palliative intent.         Nutritional status, body weight,        Group 1 maintained energy and protein intakes.
                                                                                  energy/protein intakes, QoL,            Groups 2 and 3 decreased energy (p=0.005) and protein
                                                                                  symptoms/RT toxicities.                 (p<0.05).
                                                                                                                          Nutritional status:
                                                                                  Timepoints:                             8/16 malnourished patients in group 1
                                                                                  Nutritional status, weight: baseline    improved/maintained nutritional status by end of RT and
                                                                                  and weekly during RT, 3 months          at 3 months.
                                                                                  post.                                   No patients in group 2 or 3 ever improved nutritional
                                                                                  Acceptability and compliance:           status.
                                                                                  weekly during RT.                       Morbidity:
                                                                                  Diet history: baseline and 3 months     At 3 months 90% of patients improved (incidence and
                                                                                  post.                                   severity of G1+2 anorexia, n/v, xerostomia, dysgeusia)
                                                                                  24-hour recall: weekly during RT and    in group 1 vs. 67% in group 2 and 51% in group 3
                                                                                  3 months post.                          (p<0.0001).
                                                                                  RT-induced morbidity: Weeks 2-7         QoL: End of RT: Function scores improved (p<0.003)
                                                                                  during RT and 3 months post.            with improved nut intake/status in group 1 and 2
                                                                                  QoL: baseline, final week of RT, 3      (p<0.05); worsened (p<0.05) in group 3 with
                                                                                  months post.                            deterioration in nut status.
                                                                                                                          3 months post: Group 1 maintained/improved QoL.
                                                                                                                          Group 2 and 3 maintained or worsened overall QoL.
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes                  Results                                                     Comments
                                              Quality
Raykher A, Correa L, Russo L, et al. The      IV Ø      Case series, USA            Follow-up until tube removal, death.     98% used PEG, most unable to consume any food/fluid         First paper that I have read
role of pretreatment percutaneous                                                                                            for various lengths of time. Av start day: 21+ 4 for a      that documents intentional wt
endoscopic gastrostomy in facilitating                  N=163                       All pts received standard instructions   mean of 251 + 317 days (range = 19-1949 days).              loss thru PEG feeding
                                                                                    on PEG feeding from a dietitian          PEG dependence post Rx completion = mean 196 + 115          regimen. They supplemented
therapy of head and neck cancer and
                                                        All Pts with H&N Ca         and/or nurse.                            days.                                                       “with single nutrients to
optimizing the body mass index of the obese             diagnosis who had a Pull                                             Wt loss in overwt & obese deliberate, in normal wt pts      allow provision of adequate
patient. JPEN J Parenter Enteral Nutr                   PEG inserted before Rx      • Overwt & obese pts received a          there was a small decline in BMI from 22.5 + 1.7 to 21.4    essential nutrients”.
2009;33:404-10.                                         who received surgery,         lower range of caloric                 +2 kg/m2, achieved non-significant wt gain in underwt.
                                                        CRT and/or RT depending       intake/hypocaloric regimen for         PEG complications: 99% PEGs successfully placed on
                                                        on the type of cancer.        severe obesity.                        first attempt: 79% as outpatients.
                                                                                    • Weekly follow-up during Rx by          Complications:
                                                        37% overwt at baseline,       physician and nurse specialising       < 7 days: Treated as inpt = abdo pain (n=10): all
                                                        16% obese at baseline.        in nutrition support.                  resolved with out surgery/endoscopy, aspiration
                                                                                    • Bolus feed in 50% (max 500ml),         pneumonia (n=1), bleeding (n=1)
                                                                                      gravity 46%: 3-5 times/day, 4%         < 7 days treated as OP = site infection (n=9), pain
                                                                                      pump.                                  (n=3), abdo pain (n=2), O2 desaturation (n=1), leakage
                                                                                    • Remove PEG when able to                (n=1), ileus (n=1)
                                                                                      consume orally adequate nutrients      > 7 days treated as IP: site infection
                                                                                      & fluids.                              > 7 days treated as OP: PEG leakage (n=20), pain (n=5),
                                                                                                                             dermatitis (n=2)
                                                                                    Outcomes:                                22 (13%) required replacement of PEG.
                                                                                    Age, Dx, Rx Hx, complications, any       CXRT complications: 73% xerostomia, 70%
                                                                                    hospitalisations, baseline wt, BMI       dysphagia, 70% mucositis, 45% nausea, 22% decreased
                                                                                    and changes.                             taste: only 3/163 had no documented side effects.
                                                                                                                             Interruptions: 11/163(7%) d/t severe nausea (n=3),
                                                                                                                             severe diarrhoea (n=3), pancytopenia (n=2), misc (n=4).
                                                                                                                             Hospitalisations: 74 pts (46%): 28% d/t side effects/
                                                                                                                             medical reasons, 10% dehydration, 7% failure to thrive.
                                                                                                                             Feeding complications: 28% constipation , 16% nausea,
                                                                                                                             10% vomiting, 3% reflux, 5% diarrhoea
                                                                                                                             Strictures: 12%: 18 attempted dilatation.

Raynor EM, Williams MF, Martindale RG,        IV Ø      Pharyngeal and laryngeal                                             Most common complication was external leakage from          Possible selection bias: 14%
Porubsky ES. Timing of percutaneous                     Ca.                                                                  the base of the PEG (7/43) and granulation tissue (5/43),   pts had incomplete data and
endoscopic gastrostomy tube placement in                43 out of 50 pts who had                                             1 intra-abdo abscess requiring laparotomy.                  were excluded.
                                                        PEG’s 1995-6. Insertion
head and neck cancer patients. Otolaryngol
                                                        ranged: pre-op (n=14),                                               Significantly lower complication rate in PEG insertion      PEG insertion not possible
Head Neck Surg 1999;120:479-82.                         intra-op (pre- or post-                                              after tumor removal compared to pre-op placement (27%       after tumor removal in CRT
                                                        tumor removal, (n=9),                                                vs. 57%, p=0.027).                                          alone.
                                                        >7 days post-op (n=12),
                                                        unresectable tumor (n=8).

Reese JL, Means ME, Hanrahan K,               II +      RCT, double blind, USA      1.   Osmolite (no fibre)                 Diarrhoea incidence:
Clearman B, Colwill M, Dawson C.                                                    2.   Jevity (14g fibre/L)                No fibre: 39%
Diarrhea associated with nasogastric                    N=80                        3.   Osmolite/Jevity (7g fibre/L)        Mod fibre: 19%
                                                                                                                             High fibre: 20%
feedings. Oncol Nurs Forum 1996;23:59-66;                                           Fed via pump at 50ml/hr initial,
                                                        H&N cancer pts receiving
discussion - 8.                                         post op enteral NG          increased by 25ml/hr every 12hr until    Diarrhoea less likely to occur with fibre feed p=0.0158.
                                                        feeding.                    reach goal. After 48hr, changed to
                                                                                    intermittent feeds with 4hr intervals.   No difference in incidence of constipation or other GI
                                                                                    Pts assessed pre op and daily post op.   intolerances.
                                                                                    Outcomes: Bowels, Diarrhoea = >3
                                                                                    liquid stools/d of >500ml total vol.,    Females 8 times more likely to get diarrhoea.
                                                                                    Other GI effects.
Citation                                      Level &   Study Design & Sample         Intervention & Outcomes                 Results                                                   Comments
                                              Quality
Righi PD, Reddy DK, Weisberger EC, et al.     IV Ø      Case series                   Successful insertion of RPG             Indications for PEG insertion = Changes in swallowing
Radiologic percutaneous gastrostomy:                                                  (radiological PEG) at some point        due to post-op dysphagia on MBS/bedside swallow Ax
results in 56 patients with head and neck               N=56                          during their course of treatment.       (n=26/56), delayed dysphagia/aspiration during XRT/
                                                                                                                              OT/combined Rx (22), 2=fistula.
cancer. Laryngoscope 1998;108:1020-4.
                                                        Head and neck carcinoma                                               98% success rate included 2 pts who had failed a PEG.
                                                        patients treated at a                                                 Complications (within 4/52) = 11% minor: site
                                                        tertiary care institution.                                            infections (5%) nausea/vomiting delaying feeding (5%),
                                                                                                                              2% major (peritonitis).
Ringstrom E, Matthews TW, Lampe HB,           IV Ø      Case series, UK               A retrospective chart review:           20/105 pts required G tube
Currie C. Role of percutaneous gastrostomy                                            • Incidence of postoperative            •     Average day of PEG placement day 17.4 post op
tubes in the postoperative care of patients             N=105                              gastrostomy tube insertion         •     Mean LOS for PEG pts was 26.8 days
with cancer of the oral cavity and                                                    • Complications                         •     Mean duration of use 155.5days
                                                        Patients who had surgery      • Timing of tube insertion and          •     11/20 pts had their g tube removed
oropharynx. J Otolaryngol 1999;28:68-72.                of the oral                        removal                            •     Major complications n=0, Minor complications
                                                        cavity/oropharynx, with or    • LOS                                         n=2
                                                        without neck dissection.      • Factors that are predictive of        Predictor of PEG on univariate analysis:
                                                                                           gastric tube placement.            •     Stage IV p=0.002
                                                                                                                              •     T stage p<0.001
                                                                                                                              •     Oropharynx p<0.001
                                                                                                                              •     >25% tongue resection p<0.048
                                                                                                                              Predictor of PEG on multivariate analysis:
                                                                                                                              •     T stage p=0.004
                                                                                                                              •     Oropharynx p<0.001
Riso S, Aluffi P, Brugnani M, Farinetti F,    II +      RCT, Italy                    Post op EN                              GI tolerance: IN = 17.4% STD = 28.6%                      Small numbers in sub analysis
Pia F, D'Andrea F. Postoperative enteral                                                I. EN + arg                           Plasma proteins – No difference between groups.           of malnourished pts.
immunonutrition in head and neck cancer                 N=44                           II. EN std                             Decreased day 1 in both groups p<0.05. Immune
                                                                                                                              markers - Decreased day 1 in both groups. Increased in
patients. Clin Nutr 2000;19:407-12.
                                                        Oral, pharyngeal and          Outcomes: (Pre-op and day 1,4,8         group I by day 4 and day 8. P<0.05
                                                        laryngeal cancer              post op)                                Major complications: IN = 13% STD = 23.8%. Minor
                                                                                      • Serum proteins                        complications: IN = 0% STD = 4.7%. LOS: IN =
                                                                                      • Immune markers                        25.0days STD = 28 days
                                                                                      • Complications                         Subsequent analysis:
                                                                                      • GI tolerance                          Malnourished: (n=13)
                                                                                      • LOS                                   Complications: IN = 0% STD = 71.4% p<0.05
                                                                                                                              LOS: IN = 27.8 days STD = 49 days p<0.05
                                                                                                                              Well nourished (n=31)
                                                                                                                              Complications: IN = 17.6% STD = 0%
                                                                                                                              LOS: IN = 29.2 days STD = 25 days
Roberge C, Tran M, Massoud C, et al.          IV Ø      39 head and neck ca pts on    Quality of life and tolerance of HETF         Home enteral nutrition well tolerated physically,   No comparison between
Quality of life and home enteral tube                   home enteral nutrition        was evaluated at 2 time points (1             but a substantial proportion experience             methods of home enteral
feeding: a French prospective study in                                                week post hospital discharge and 3            psychosocial distress.                              nutrition i.e. NG vs. PEG.
                                                        Case series, France           weeks later) and compared (with         QoL at Day 7 (H+N and oes):
patients with head and neck or oesophageal
                                                                                      patients being taken as their own              Mean global QoL: 45                                No comparison of QOL for
cancer. Br J Cancer 2000;82:263-9.                      n=39                          controls) 1 week (day-7) and 4 weeks           Functional scales: physical scales scored the      pts without enteral feeding –
                                                                                      (day-28) after returning home.                 lowest (45)                                        other studies have shown ca
                                                        39/146 (27%) consecutive      Education prior to discharge by                Symptom scales:                                    treatment impact on QOL.
                                                        patients who had enteral      dietitian.                                    - Nausea, vomiting, constipation, diarrhoea,
                                                        nutrition during the study                                                  financial difficulties grouped as low impact        No information on treatment
                                                        period and treated for head   80% NG and 20% PEG.                           - Pain, dyspnoea, insomnia, appetite loss:          regimes. Not clear when
                                                        and neck or oesophageal                                                     intermediate impact                                 assessments were made
                                                        cancer were eligible for      Outcomes:                                     - Fatigue: scored highest                           relative to course of
                                                        enrolment.                    QOL and physical tolerance.                   - H&N 35 symptom scores (n=35 H+N patients) in      treatment.
                                                                                                                                    same range as those of QLQ-C30 (nutritional and
Citation   Level &   Study Design & Sample   Intervention & Outcomes              Results                                                     Comments
           Quality
                                             Generic QoL data – EORTC QLQ-             speech aspects associated with the higher scores)      General QoL questionnaire
                                             C30                                       - Pain in both questionnaires correlated (p=0.04)      results and tolerance of
                                             Head and neck and oesophageal             - Social functioning in both were complementary        HETF results are for both
                                             disease-targeted measures of QoL –         Tolerance of HETF at Day 7 (H+N and oes):             H+N and OES.
                                             H+N35 and OES24 modules.                   - Compliance measured through number of meals
                                             Tolerance of HETF and family and           and caloric intake (median: 4 feeds, 2100kcal/day)
                                             social impact: 60 item self-               - 1/3 of patients: ETF + grinding food (no higher
                                             administered questionnaire.                on functioning scale scores than those exclusively
                                                                                        ETF)
                                                                                        - ½ of patients: required systemic help with set up
                                                                                        of HETF (90% of these: help from family)
                                                                                        - Physical tolerance
                                                                                       - 18-43% digestive complaints (nausea, reflux,
                                                                                       wind ), 44% hunger, 77% thirst
                                                                                        Daily activities:
                                                                                       - HETF induced discomfort in activities (dressing
                                                                                       40%, washing 54%), 25% did not resume daily
                                                                                       activities, 20% did not resume leisure activities
                                                                                        Psychological tolerance:
                                                                                       - 69% longed to have tube removed, 45% worried
                                                                                       about accidental tube removal
                                                                                       - 1/3 uncomfortable about body image
                                                                                       - 51% felt feeding time was too long
                                                                                       - 13% sleeping disorder, 13% depression
                                                                                       - emotional functioning lower in depressed
                                                                                       patients (p=0.022)
                                                                                        Family and social relationships:
                                                                                       - 13-34% reported changes in relationships
                                                                                       (mostly improvements, 15% - HETF prevented
                                                                                       relationships)
                                                                                       - 23% never went out
                                                                                        Changes in QoL between day 7 and day 28
                                                                                        (n=30):
                                                                                        - Global QoL: significantly improved at p<0.10
                                                                                        - Constipation: significantly improved at p<0.05
                                                                                        For H&N-35 (n=28): coughing, social function,
                                                                                        speech body image/sexuality: all significantly
                                                                                        improved at p<0.05 level
                                                                                        Changes in tolerance of HETF between day 7 and
                                                                                        day 28:
                                                                                        - Improvement (p=0.016) for HETF+food (mixed
                                                                                        diet)
                                                                                        - No difference in physical, emotional functioning
                                                                                        or global QoL between exclusive ETF and mixed
                                                                                        diet patients
                                                                                        Concordance b/w H&N35 and HETF tolerance
                                                                                        questionnaires:
                                                                                        - 16/30 (53%) considered intolerant (based on
                                                                                       depression, relationships, going out in public,
                                                                                       visiting and having visitors)
                                                                                        - These 16: body image/sexuality score and social
                                                                                       function score significantly higher than other
                                                                                       patients (p=0.004 and p=0.055).
Citation                                     Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                      Comments
                                             Quality
Rodriguez-Cuevas S, Labastida S, Gutierrez   II Ø      RCT, Mexico                 Intervention group (n=18): Early oral   Fistula rates (NS):
F, Granados F. Oral feeding after total                                            feeding – commenced day 7 post op.      Early: n=2; Late: n=0
laryngectomy for endolaryngeal cancer. Eur             N=35                        Control group (n=17): Late oral
                                                                                   feeding – commenced day 14 post op.     LOS (median days) (p=0.001)
Arch Otorhinolaryngol 1995;252:130-2.
                                                       Patients with ca larynx                                             Early: 7 days; Late: 14 days
                                                       undergoing laryngectomy.    Outcomes:
                                                                                   Fistulas and LOS
Rogers SN, Thomson R, O'Toole P, Lowe        III-2 Ø   Comparative Cohort          No PEG placement n=193                  1. PEG Status & UW-QoL Version 4 questionnaire               No nutritional status data
D. Patients experience with long-term                  study, UK                                                               comparing Group 1,2 and 3:                               evaluated for group 1,2,3 and
percutaneous endoscopic gastrostomy                                                PEG removed n=30                        Domain scores:                                               therefore question
                                                       N=243                                                               P<0.001 for all domains except for shoulder (p=0.001) +      effectiveness of study with
feeding following primary surgery for oral
                                                                                   PEG in situ n=20                        anxiety (p=0.0001)                                           primary focus on PEG
and oropharyngeal cancer. Oral Oncol                   Previously untreated Oral                                           Health related QOL score (P=<0.001)                          outcomes.
2007;43:499-507.                                       and Oropharyngeal           Postal Survey of questionnaires         Overall QoL score (P=0.02)
                                                       Squamous Cell Carcinoma     completed and returned. Initial non     Domain Importance:
                                                       treated by primary          responders re-sent the questionnaires   P>1.0 except for pain (P<0.001), speech (p=0.03), mood
                                                       surgery.                    after 4 weeks.                          (p=0.04)
                                                                                                                           PEG Status & UW-QoL Version 4 questionnaire to
                                                                                   Outcome: QOL                            compare group 1 (Never had PEG) and group 2 (PEG
                                                                                                                           removed):
                                                                                                                           Domain Scores: >1.0 except for appearance (P=0.08),
                                                                                                                           swallowing (P=0.03), speech (P=0.07) and saliva
                                                                                                                           (P=0.002)
                                                                                                                           2. Chewing:
                                                                                                                           Chewing (85% unable to chew soft solids).
                                                                                                                           Swallowing (40% could not swallow, 50% only swallow
                                                                                                                           liquid). Taste (61% unable to taste any food).
                                                                                                                           Nil reported outstanding or very good HRQOL,
                                                                                                                           compared to 50% in Group 2 (PEG removed) and 36%
                                                                                                                           in group 1 (Never had PEG).
                                                                                                                           3. Self-designed 24 item PEG questionnaire:
                                                                                                                           Missing data in 25-30% on some items.
                                                                                                                           Major problems with PEGs:
                                                                                                                              36%: affect on overall QOL (p=0.001)
                                                                                                                              30%: redness / irritation (p=0.04)
                                                                                                                              25%: intimate relationships (p = 0.04)
                                                                                                                              25%: dirtying of clothes (p= 0.04)
                                                                                                                              23%: leakage (p=0.05)
                                                                                                                              bleeding (p=0.05)
                                                                                                                              interference in family life (p=0.03)
                                                                                                                              32%: types of clothes to be worn (p=0.22)
                                                                                                                              19%: discomfort (p=0.57)
                                                                                                                              29%: interfere with hobbies / leisure (p=0.71)
                                                                                                                              28%: social activities (p=0.16)
                                                                                                                           4. PEG status and Texture and type of food eaten
                                                                                                                              comparing Group 1,2, and 3:
                                                                                                                              P<0.001 for full diet, peanuts, all meats or similar
                                                                                                                              textures for vegetarians, carrot, celery, dry bread and
                                                                                                                              crackers, soft chewable foods, soft food requiring no
                                                                                                                              chewing, warm liquids, non oral feeding PEG
                                                                                                                              feeding.
                                                                                                                              Fisher exact test to compare Group 1, and 2: all were
                                                                                                                              P>0.15 except for peanuts p=0.07).
Citation                                       Level &   Study Design & Sample         Intervention & Outcomes                 Results                                                    Comments
                                               Quality
Rustom IK, Jebreel A, Tayyab M, England        III-2 Ø   Comparative cohort, UK        Gastrostomy insertion and f/up for 18   •   No difference in demographics btw 3 grps
RJA, Stafford ND. Percutaneous                                                         months from insertion+ outcomes:        •   Overall complications = 36 (46%) with 32 minor
endoscopic, radiological and surgical                    N=78 (PEG = 40, RIG =                                                     complication (41%) and 4 major (5%)
gastrostomy tubes: a comparison study in                 28, SUR = 10)                 •    Minor complications (peri-         •   Overall short-term complication (<30 days) = 18
                                                                                            stomal leakage, superficial            (23%)
head and neck cancer patients. J Laryngol                All H&N cancer patients            cellulitis, tube dislodgement,     •   Overall long-term complication (>30 days) = 17
Otol 2006;120:463-6.                                     that had a PEG, RIG or             tube blockage or any                   (22%)
                                                         SUR insertion.                     combination of these)              •   Overall mortality = 4% (within 30 days of
                                                                                       •    Major complications                    gastrostomy insertion) (PEG = 0, RIG = 2, SUR = 1)
                                                                                            (peritonitis, gastro-intestinal    •   Similar minor complication rates btw 3 groups
                                                                                            bleeding and pulmonary,                (Table 2)
                                                                                            cardiac and neurological events    •   Higher mortality rate with RIG compared to PEG
                                                                                       •    Mortality                          •   Lower rate of dislodgement and blockage rates in
                                                                                                                                   PEG group



Rutter CE, Yovino S, Taylor R, et al. Impact   IV Ø      Retrospective chart audit     This study analyzes the relationship    Early PEG tube placement was correlated to:                Early placement of PEG
of early percutaneous endoscopic                         Baltimore, USA                between timing of PEG placement                                                                    tubes for nutritional
gastrostomy tube placement on nutritional                                              and weight loss, rates of               •   A lower % weight loss (R = 0.495 and R2 = 0.245,       supplementation was
                                                         N=111 (consecutive)           hospitalization for nutritional             p < .001)                                              associated with decreased
status and hospitalization in patients with
                                                         81% pts received PEG at       support, treatment time, rates of PEG   •   Decrease in total in-patient days (R = 0.21, p=.012)   weight loss during CRT and
head and neck cancer receiving definitive                some stage.                   complications and dependence, and                                                                  less persistent weight loss
                                                                                                                               •   Lower risk of admission for nutritional deficits
chemoradiation therapy. Head & Neck                                                    persistent weight loss following            (R = 0.26, p = .01)                                    after the completion of
2010;15:15.                                              Locally advanced HNSCC        treatment completion.                                                                              therapy, compared with
                                                         & concurrent CRT (varied                                              Disease control was the only predictor of PEG              patients who deferred
                                                         chemo & radiation             “PEG tubes were removed once            dependence.                                                placement of a PEG tube
                                                         protocols).                   patient was able to maintain weight                                                                until nutritional deficits
                                                                                       on oral intake alone without the need   No differences were seen in PEG complication or            developed.
                                                         All pts offered               for any supplemental PEG tube           dependence rates with earlier placement.
                                                         prophylactic PEG. Weekly      feedings.”
                                                         review of weight & tube                                               Patients who had a PEG tube placed at any time during
                                                         feeds by team which                                                   treatment had a mean weight loss of 9.2% of their pre
                                                         included “nutritionist” but                                           treatment baseline weight, compared with a mean weight
                                                         no speech pathologist                                                 loss of 11.8% in patients without a PEG tube (p = .064).
                                                         mentioned during                                                      However no difference in the number of hospitalization
                                                         treatment.                                                            days for nutritional issues and no difference in overall
                                                                                                                               treatment time between the 2 patient groups.
                                                         Correlation analysis
                                                         independent-samples
                                                         t tests.
Citation                                      Level &        Study Design & Sample      Intervention & Outcomes                  Results                                                       Comments
                                              Quality
Sakhi A. Pre-radiotherapy plasma              III-2 Ø        Case control, Norway       15 antioxidant biomarkers and 4          Lower in HNSCC pts compared to controls:                          F/U samples only taken
carotenoids and markers of oxidative stress   intervention                              oxidative stress biomarkers were            Dietary antioxidants (carotenoids – p<0.001,                   in 60/78 pts (77%).
are associated with survival in head and                     N=78 HNSCC having          measured in plasma samples.                 tocopherols – p<0.07 i.e. NS and Ascorbic acid-                Not a lot of detail on how
                                              IV Ø           PORT or RT alone for 5-7                                               p<0.001). Ferric reducing antioxidant power (FRAP)             intake was measured (?
neck squamous cell carcinoma patients: a
                                              prognosis      weeks                      Time points: Before initiation of RT        - p<0.05. Modified FRAP p<0.001                                FFQ).
prospective study. BMC Cancer 2009;9:458.                                               and final week of RT.                    Higher in HNSCC pts compared to controls:                         Interesting concept that
                                                             N=100 healthy controls                                                 Total hydroperoxides (d-ROMS) i.e. a marker for                suggests patients with
                                                                                        Outcomes:                                   oxidative stress – p<0.001. These increased during             HNSCC already have
                                                                                        Plasma antioxidant levels, survival.        RT. p<0.001                                                    increased oxidative stress
                                                                                                                                 Positively associated with increased survival:                    prior to RT which further
                                                                                        60 HNSCC had F/U samples                    Higher levels of plasma carotenoids associated with            increases this.
                                                                                        obtained at end of RT; of these, 24         a prolonged progression-free survival (HR Ratio:               Study is based on plasma
                                                                                        required assisted nutrition during RT.      0.42, 95%CI: 0.20-0.91, p=0.03).                               carotenoids being a
                                                                                                                                    Significant decline in plasma levels of dietary                reflection of F&V intake
                                                                                                                                    antioxidants including all carotenoids (except ß-              (? quality of evidence
                                                                                                                                    carotene) p<0.001 for all except α-carotene where              confirming this is
                                                                                                                                    p<0.05.                                                        actually an accurate
                                                                                                                                    24 pts received assisted enteral nutrition fortified           biomarker).
                                                                                                                                    with ß-carotene (130µg/ml) during RT – sub analysis
                                                                                                                                    excluding pts on EN also showed decline for ß-             ? confusing that high
                                                                                                                                    carotene (29%, p=0.06).                                    oxidative stress is beneficial
                                                                                                                                 Clinical Outcome                                              in terms of survival but
                                                                                                                                     Median f/u time of 28 months (range 11-48 months),        suggestions that studies
                                                                                                                                                                                               should look at increasing
                                                                                                                                     25 pts deceased, 23 died of HNSCC, 1 died of lung
                                                                                                                                                                                               F&V – presumably for their
                                                                                                                                     cancer and 1 of unknown cause. 35 pts have
                                                                                                                                                                                               anti-oxidant capacity
                                                                                                                                     experienced disease progression, 10 relapsed pts are
                                                                                                                                     alive, 18 relapsed patients are dead and 7 patients are   before/during/after Rx (which
                                                                                                                                                                                               would be quite difficult to
                                                                                                                                     dead without previous relapse or re-growth of
                                                                                                                                                                                               do).
                                                                                                                                     tumour.
                                                                                                                                     Projected 3-year progression-free survival and
                                                                                                                                     overall survivals were 55% and 68%.
                                                                                                                                 Pre-RT Levels
                                                                                                                                     Above median-values of several plasma carotenoids
                                                                                                                                     were significantly associated with improved
                                                                                                                                     progression-free survival – in univariate regression
                                                                                                                                     analysis, high pre-RT plasma levels of total
                                                                                                                                     carotenoids and single carotenoids were significantly
                                                                                                                                     associated with prolonged progression-free survival.
                                                                                                                                     Plasma α-carotene did also show a close to
                                                                                                                                     significant association with prolonged progression-
                                                                                                                                     free survival (p=0.06).
                                                                                                                                 Changes during RT
                                                                                                                                    Patients with a high relative decrease in plasma
                                                                                                                                    levels of FRAP during RT had a prolonged
                                                                                                                                    progression-free survival which remained significant
                                                                                                                                    after adjusting for confounding factors (p=0.05).
                                                                                                                                    Significant weight loss (3.7%, p<0.001), however,
                                                                                                                                    no significant correlation between wt loss and
                                                                                                                                    reduction in plasma antioxidant levels were observed
                                                                                                                                    (discussion section: -> suggesting dietary intake
                                                                                                                                    doesn’t account for this decline but possibly more
                                                                                                                                    due to RT).
Citation                                        Level &   Study Design & Sample         Intervention & Outcomes                 Results                                                       Comments
                                                Quality
Sakhi AK, Bohn SK, Smeland S, et al.            III-2 -   Comparative Control           Intervention: Patients were men and     In the patient group plasma lutein (P 0.001), zeaxanthin
Postradiotherapy plasma lutein, alpha-                    Study                         women ≥18 years with squamous cell      (P <0.001), α-carotene P <0.001), β-carotene (P <0.001),
carotene, and beta-carotene are positively                Norway                        carcinoma of the head and neck          lycopene (P 0.003) and total carotenoids (P <0.001) were
                                                                                        receiving radiotherapy only or          significantly lower compared to the controls.
associated with survival in patients with
                                                          Controls = 51                 postoperative radiotherapy to a total
head and neck squamous cell carcinoma.                    Patient group = 29            dose of minimum 60 Gy.                  Among dietary antioxidants, plasma lutein (P=0.04), α-
Nutrition & Cancer 2010;62:322-8.                                                                                               carotene (P =0.06), and β-carotene (P= 0.04) levels were
                                                          Dietary intake of             Outcomes:                               positively associated with progression-free survival at 55
                                                          antioxidants, was             Plasma levels of antioxidants were      months post radiotherapy.
                                                          estimated using a 24hr        taken post radiotherapy.
                                                          food recall and compared
                                                          to plasma samples in order
                                                          to establish patients
                                                          survival rate.
Salas S, Deville J-L, Giorgi R, et al.          III-3 Ø   Prognosis study, France       Retrospective correlations between      All biological nutritional factors correlated with            ? Reliability of PINI, NRI
Nutritional factors as predictors of response                                           nutritional factors at baseline and     response. With multivariate analyses only CRP remained        and ORP as malnutrition
to radio-chemotherapy and survival in                     N=72                          response to treatment and survival.     significant.                                                  measures.
unresectable squamous head and neck                                                                                             • Statistical correlation between Albumin and EFS.
                                                          Patients with unresectable    Nutritional assessment and                  With multivariate analyses Albumin remained               •   CRP and Albumin were
carcinoma. Radiother Oncol 2008;87:195-                   head and neck cancer          biochemical profiles: on admission -        significant.                                                  the only significant
200.                                                      treated by concomitant        CRP, albumin, prealbumin,               • Albumin, CRP, orosomucoid influenced survival in                predictors in the
                                                          radio-chemotherapy.           orosomucoid, weight, weight history,        univariate analysis.                                          multivariate analyses
                                                                                        BMI, PINI, OPR, NRI.                    • Response to radio-chemotherapy and staging were                 (these factors alone are
                                                                                                                                    statistically correlated with OS. In multivariate             not reliable malnutrition
                                                                                        Outcomes:                                   analyses response to radio-chemotherapy remained              indicators).
                                                                                        • Post treatment follow up (18.4-           significant.                                              • Weight history and BMI
                                                                                            25.9 months post)                                                                                     (the more reliable
                                                                                        • Response RT/chemo                                                                                       nutritional indicators in
                                                                                        • Survival (EFS + OS)                                                                                     this study) were never
                                                                                                                                                                                                  significantly correlated.
Salas S, Baumstarck-Barrau K, Alfonsi M,        II +      RCT, multicentre, France      Prophylactic PEG (n=21) vs. standard    •   Median withdrawal of PEG+ 1.5 months (range=1-            Despite indications for PEG
et al. Impact of the prophylactic gastrostomy                                           (n=18)                                      2).                                                       being very broad
for unresectable squamous cell head and                   N=39                                                                  •   13/18 pts in the standard care group needed PEG.          (dysphagia/severe
                                                                                        Std care = Peg only when indicated      •   No significant diff in change in BMI at end of RX or      odynophagia, dehydration
neck carcinomas treated with radio-
                                                          Histologically confirmed      by general & nutrition al status            6/12.                                                     and/or wt loss >15%) 13 of
chemotherapy on quality of life: Prospective              locally advanced (stage III   (dysphagia/severe odynophagia,                                                                        18 pts in the standard care
                                                                                                                                •   QOL only significant diff for dyspnoea & speech
randomized trial. Radiother Oncol                         & IV) SCC H&N, BMI>           dehydration and/or wt loss >15%).                                                                     group needed a PEG.
                                                                                                                                    problems.
2009;93:503-9.                                            20, wt loss<10% previous                                              •   No significant diff in global health status b/t groups.
                                                          6/12, Karnofsky               Baseline, first day of week 4 of Rx,    •   QOL decreased over time & then increased with stat        Note median PEG use was
                                                          performance index > 70        end of Rx, 6/12.                            significant changes in both SF36 and EORTC scales.        only 1.5 months post-RX &
                                                                                                                                                                                              the effect was reported at
                                                                                                                                •   QOL was significantly higher for the prophylactic
                                                                                        Outcomes:                                                                                             6/12.
                                                                                                                                    PEG group at 6/12 for physical composite score-
                                                                                        • BMI                                       SF36, mental composite score-SF36 and EORTC
                                                                                        • Karnofsky performance scale                                                                         Surprising result: QOL was
                                                                                                                                    global health status at 6/12.
                                                                                        • QOL                                                                                                 impacted but not BMI:
                                                                                                                                •   Higher BMI & lower Karnofsky index at baseline
                                                                                                                                                                                              authors postulate this may be
                                                                                                                                    were significant related to higher QOL at 6/12.
                                                                                                                                                                                              d/t nutrition al status.
                                                                                                                                Youth, female gender, lower educational status and
                                                                                                                                higher QoL at baseline were linked to higher 6/12
                                                                                                                                mental composite score-SF36, being female, single and
                                                                                                                                higher physical composite SF36 at baseline were assoc
                                                                                                                                with higher 6/12 EORTC global health status.
Citation                                         Level &     Study Design & Sample         Intervention & Outcomes                 Results                                                   Comments
                                                 Quality
Sanguineti G, Gunn GB, Parker BC, Endres         III-3 Ø     Retrospective comparison      Intervention: PEG insertion             N=22 required PEG (15 having hyperfractionated, 7         All PEG’s placed as needed
EJ, Zeng J, Fiorino C. Weekly dose-volume                    study, Baltimore                                                      non-hyperfractionated)                                    during Rx (non- prophylactic)
parameters of mucosa and constrictor             Prognosis                                 Outcomes: Predictors of PEG use -                                                                 as per physician (criteria:
                                                             N=59 (n=22 with PEG;          specifically weekly dose-volume         OM DVHw were strongly correlated with the risk of         >10% wt loss during Rx,
muscles predict the use of percutaneous
                                                             n=37 without PEG)             histogram or oral mucosa (OM            PEG use:                                                  protracted symptoms and
endoscopic gastrostomy during exclusive                                                    DVHw)                                   -   OM DVHw cutoff values: V9.5 Gy/week <64cm3            inadequate pain control).
intensity-modulated radiotherapy for                         T1-4 oropharynx cancers                                                   and V10 Gy/week <54cm3
oropharyngeal cancer. International Journal                  treated with IMRT alone,                                              -   OM V9/5Gy/week (≥64 vs <64cm3) was most
of Radiation Oncology, Biology, Physics                      either hyperfractionated or                                               predictive parameter (p=.0015) even in the non-
2011;79:52-9.                                                once-daily fractionation                                                  hyperfractionated group (p=.01)
                                                             (no chemo or surgery).
                                                                                                                                   Reducing the dose to constrictors (and larynx) may also
                                                                                                                                   lead to reduced risk of PEG insertion.

Sanz Ortiz J, Moreno Nogueira JA, Garcia         IV -        Observational longitudinal    Clinical and wt data collected from     18% had low BMI.                                          Does not report how they
de Lorenzo y Mateos A. Protein energy                        prospective study, multi-     patients by questionnaire and                                                                     calculate incidence of PEM.
malnutrition (PEM) in cancer patients. Clin                  centre, Spain                 interview by medical staff.             22% pts overweight/obese.
Transl Oncol 2008;10:579-82.
                                                             N=561                                                                 Recent wt loss reported in 90% patients.
                                                             (H&N n= 198)
                                                                                                                                   Nutrition impact symptoms reported in 96% patients.
                                                             Cancer outpatients who
                                                             had a BMI registered.                                                 7% incidence of PEM.


Sartori S, Trevisani L, Tassinari D, et al.      III-3 Ø     Comparative cohort, Italy     Cost analysis included PEG              PEG Complications:                                        No nutritional data from
Cost analysis of long-term feeding by                                                      procedure, enteral feeding, and             Procedure related mortality = 0% / (0/34)             baseline.
percutaneous endoscopic gastrostomy in                       n=34 PEG                      patient care compared to patients who       60d mortality = 8.8% / (3/34)                         No treatment data.
                                                             n=11 NGT                      were unable to, or refused a PEG and        N= 2 site infections requiring antibiotics and 4      No PEG data with % oral
cancer patients in an Italian health district.
                                                                                           had an NGT.                                 additional hospital visits                            intake.
Support Care Cancer 1996;4:21-6.                             Unresectable, relapsed or                                                 No peg replacement
                                                             locally advanced HNC          Outcomes:                                   No hospital admission
                                                             requiring a PEG.                  Mean daily cost                         Low rate of long term treatments / medical /
                                                                                               PEG complications                       nursing intervention (5.9%)
                                                                                               Enteral feeding
                                                                                                                                   Enteral Feeding:
                                                                                               Survival
                                                                                                                                        Mean intake 1464 mls/d equating to mean 113kj/d
                                                                                                                                        and 1.12g Protein
                                                                                           Post discharge follow up till:
                                                                                                                                        Below the Harris Benedict formula but some had
                                                                                                Death
                                                                                                                                        oral intake
                                                                                                Removal of tube
                                                                                                End of study                       Location of follow up:
                                                                                           Review - Monthly by the physician           Outpatient: n=17 until death or end of follow up
                                                                                           & Fortnightly by skilled nurse              Home care unit: n=8
                                                                                                                                       Outpatients to Home care unit: n=9
                                                                                                                                   Survival:
                                                                                                                                        N= 25 due to underlying disease
                                                                                                                                        N= 2 moved to another district 226 & 228 days
                                                                                                                                        after PEG
                                                                                                                                        N= 7 alive with:
                                                                                                                                        - n=1 PEG removed after 639d due to cure
                                                                                                                                        - long term follow up: 180.5d/pt (range 47-639)
                                                                                                                                        - total number of days for PEG use = 6140d
Citation                                     Level &   Study Design & Sample         Intervention & Outcomes                 Results                                                      Comments
                                             Quality
                                                                                                                             Mean daily cost:
                                                                                                                                 PEG placement: 2500
                                                                                                                                 Enteral nutrition: 24,510
                                                                                                                                 Patient care: 1880
                                                                                                                                 Per patient: 28,890
                                                                                                                                 Feeding via NGT: 27,340
                                                                                                                                 34d - Duration of PEG use that reduced the cost of
                                                                                                                                 its placement to less than 1/3 of the total daily cost
                                                                                                                                 52d – Cost of enteral nutrition + patient care was ¾
                                                                                                                                 of the daily cost of feeding via PEG
                                                                                                                             PEG v NGT:
                                                                                                                                 NG requires more follow up (Medical– 1.48:1
                                                                                                                                 Nursing - 1.22:1)
                                                                                                                                 Cost of NG negligible especially when PEG used
                                                                                                                                 over long time: 30-60d

Saunders JR, Jr., Brown MS, Hirata RM,       IV Ø      Case series                   Routine “push” PEG placement -          97% success. 5% complications: prolonged ileus (1%),         Does not comment on
Jaques DA. Percutaneous endoscopic                                                   25% placed at endoscopy and 60%         local skin infection (1%), early tube dislodgement (4%)      training of staff who insert
gastrostomy in patients with head and neck             N=126                         during resection.                       of which 2% required laparotomy + open gastrostomy.          PEG’s.
                                                                                                                                                                                          No data on weight loss
malignancies. Am J Surg 1991;162:381-3.
                                                       Pts with head and neck                                                No aspiration or mortality.                                  reported.
                                                       malignancy receiving                                                       Mean placement 6.5 months                               Reports good pt acceptance
                                                       combined therapy, with                                                                                                             but not measured.
                                                       significant wt loss and
                                                       those who had had
                                                       previous RT.

Saydam L, Kalcioglu T, Kizilay A. Early      IV Ø      Case series, Turkey           Early oral feeding post op: Day 1 –     Overall fistula rate was 12.5%.
oral feeding following total laryngectomy.                                           sips water, Day 2-3 clear fluids or
Am J Otolaryngol 2002;23:277-81.                       N=48                          milk, Day 4-5 soft diet.                Partial pharyngectomy with laryngectomy was the only
                                                                                                                             significant factor contributing to fistula development (P=
                                                       Patients who had a total or   Outcome:                                0.04).
                                                       partial laryngectomy or           Fistula
                                                       pharyngolaryngectomy.

Schattner MA, Willis HJ, Raykher A, et al.   IV Ø      Case series, USA              Use of long term enteral feeding: for   Wt loss on 100kJ/kg from oral diet and tube feeds, wt        No definition of tube
Long-term enteral nutrition facilitates                                              36 +/- 41 months.                       maintenance on 150kj/kg, and repletion on 200kJ/kg           dependency defined by %
optimization of body weight. JPEN J                    N=39                                                                  after completion of cancer treatment. Alternative            oral or % enteral feeding.
                                                                                     Patients grouped according to their     feeding can be required for up to mean 36 months due to
Parenter Enteral Nutr 2005;29:198-203.
                                                       Patients who have been        BMI at initiation of enteral feeding:   dysphagia.                                                   No data with regard to
                                                       cured of their head and                                                                                                            intensity and frequency of
                                                       neck cancer and remained      Goal 1, Weight maintenance:             Overall for the group:                                       dietetic intervention.
                                                       dependant on enteral          BMI: 19.0 – 24.9                        BMI: Start of EN: 23.4 Mean current: 22.7
                                                       nutrition for more than 1     Goal 2, Weight gain: BMI=<19.0          Goal achievement across 3 groups:                            No description of criteria for
                                                       year due to persistent        Goal 3, Weight loss: BMI>25             Normal BMI: n=33 (85%): maintained, achieved or              tube insertion and timelines
                                                       dysphagia.                                                            trended towards.                                             for when this was inserted
                                                                                     Outcome:                                Duration of tube use: 36+/-41 months as median time.         from pre-illness weight.
                                                                                     Wt and BMI at end of study              Type of tube placement:
                                                                                                                             PEG: n=37; PEJ: n=2                                          No patient characteristics of
                                                                                                                             Kcals:                                                       diagnosis or treatment.
                                                                                                                             Average total/day: 2231kcals
                                                                                                                             EN: 1892kcals with a range of 750-3250kcals                  Small numbers.
                                                                                                                             Oral: 339 with a range of (0-1000)
Citation                                     Level &   Study Design & Sample    Intervention & Outcomes                 Results                                                    Comments
                                             Quality
                                                                                                                        Group 1: Weight Maintenance (n=20): NS
                                                                                                                        Mean BMI 22.3 to 22.4 NS
                                                                                                                        Wt maintenance N=17 (84%)
                                                                                                                        Tube duration: Median = 38 months
                                                                                                                        Average daily kcal: 35 +/- 6kcals/kg
                                                                                                                        Became underweight n=3 (16%)
                                                                                                                        Reason for weight loss:
                                                                                                                                 Premature attempt to transition from EN-ON
                                                                                                                                 Reluctance to use the feeding tube and non
                                                                                                                                 compliance
                                                                                                                                 Respiratory complications requiring repeated
                                                                                                                                 hospital admission
                                                                                                                        Tube duration:
                                                                                                                                 Median of 20m

                                                                                                                        Group 2: Weight Gain (n=7):
                                                                                                                        BMI:16.5 to 19.2 P<0.02
                                                                                                                        Tube duration:
                                                                                                                                  Median time = 59 +/- 35 months
                                                                                                                        Kcals: Average daily kcal: 44 +/- 4kcals/kg

                                                                                                                        Group 3: Weight Loss (n=12):
                                                                                                                        BMI:30.2 to 27.3 P=<0.0001
                                                                                                                        Tube duration:
                                                                                                                                   Median time = 59 +/- 35 months
                                                                                                                        Kcals for successful weight loss: Average daily kcal: 28
                                                                                                                        +/- 7 kcals/kg

                                                                                                                        Tube Complications:
                                                                                                                                20% = mild leakage
                                                                                                                                20% = mild infection requiring antibiotics
                                                                                                                                5% = buried bumper in n=2 who gained
                                                                                                                                weight ?cause
                                                                                                                                15% = constipation and diarrhea

Schurink CA, Tuynman H, Scholten P, et al.   III-3 Ø   Comparative cohort,      Period I - Indication for PEG and the   PEG insertion successful in 254/263 cases.                 A difference (not stat sig)
Percutaneous endoscopic gastrostomy:                   Netherlands              procedure was individually judged                                                                  was shown between period I
complications and suggestions to avoid                                          (n=167 insertions).                     •   Overall minor complications = 13% (n=35), n=21 in      and period II in terms of
                                                       N=263 (70% had H&N                                                   period I and n=14 in period II (p=0.71).               minor and major
them. Eur J Gastroenterol Hepatol
                                                       cancer, 20% neuro        Period II - Strict protocol was         •   Overall major complications = 8% (n=22), 9.5% in       complications.
2001;13:819-23.                                        disorder, 11% upper GI   implemented after several major             period I and 6% in period II (p=0.46).
                                                       motility disorder).      complications occurred (n=96            •   n=1 case of metastatic seeding.
                                                                                insertions).                            •   Of H&N patients, n=18 (10%) of 183 patients had
                                                       All adults 18yrs+ that   PEG insertion ‘pull’ technique, adm         major complications versus n=4 (5%) of remaining
                                                       received a PEG.          for 24hrs post-PEG, Abx                     80 patients (p=0.23).
                                                                                prophylactically – then followed up
                                                                                to median of 111 days (range 10-893
                                                                                days).

                                                                                Frequency and severity of
                                                                                complications: minor (gastro appt
                                                                                required i.e. leakage, wound
                                                                                infection, pain at site) and major
                                                                                complications (PEG removal required
                                                                                and/or hospital admission).
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                Results                                                       Comments
                                               Quality
Schweinfurth JM, Boger GN, Feustel PJ.         IV Ø      Retrospective case series    Compared 2 groups:                     Of the 38 pts method of initial nutrition support post op -   Confounding not discussed:
Preoperative risk assessment for                                                                                             14 PEG (5 placed pre op): 24 NGT.                             alcohol intake is linked with
gastrostomy tube placement in head and                   N=142                         I. Nutrition support for >6 weeks                                                                   Ca risk, not just g-tube
                                                                                          (n=38)                             PEG; total 24 placed post op.                                 placement.
neck cancer patients. Head Neck
                                                         HNC undergoing surgery       II. Nutrition support for <6 weeks     9 pts progressed to PEG removal, 12 remained with
2001;23:376-82.                                                                           (104)                              PEG.
                                                                                                                             1 remained with NGT, 4 died.
                                                                                      Risk factors associated with long
                                                                                      term post op nutrition support.        Increased risk of G tube:
                                                                                                                             • All heavy alcohol users (>.2oz/day)
                                                                                                                             • Base of tongue (OR=2.8)
                                                                                                                             • Surgical resection of BOT or pharynx
                                                                                                                             • Mandibulectomy (p<0.05)
                                                                                                                             • Reconstruction with a pec major flap
                                                                                                                             • Post-op RT (OR=7.2)
                                                                                                                             • Large tumor size (p<0.01)


Scolapio JS, Spangler PR, Romano MM,           IV Ø      Retrospective case series    Evaluated outcomes of wt, unplanned    •   Mean initiation of feeding –day 10 in prophylactic        Selection bias in those
McLaughlin MP, Salassa JR. Prophylactic                  of outcomes of               treatment interruption and admission       PEG (= av day of side effects commencing), vs. N/g        selected for PEG placement:
placement of gastrostomy feeding tubes                   gastrostomy tubes placed     with prophylactic peg compared to no       at day 23 after initiation of Rx.                         not clearly defined.
                                                         before XRT in head and       peg.                                   •   95% of pts used the prophylactic PEG. Age and
before radiotherapy in patients with head
                                                         neck cancer patients in                                                 gender did not affect length of PEG use.                  Groups were not similar at
and neck cancer: is it worthwhile? J Clin                those likely to have                                                                                                              baseline. No randomization.
                                                                                                                             •   Despite goal intakes of 25-30kcal/kg 90% pts lost wt
Gastroenterol 2001;33:215-7.                             difficulty after XRT.                                                   d/t bloating/ nausea/ G tube malfunction. 66% of all
                                                         1995-1999.                                                              pt lost >5% wt – (with peg 43%, no peg 71%).              Poor statistics.
                                                                                                                             •   Patients with peg had admissions for nutrition
                                                         N=54. 76% prior to XRT,                                                 /dehydration =13% compared to 34%. Overall                Poor definition of selection
                                                         24% during XRT (mean=                                                   admission rate for all reasons not influenced by peg      criteria for PEG insertion.
                                                         day 10) Pull=41,                                                        (note 70% of admissions are nutrition related
                                                         radiological=10,                                                        though).
                                                         surgical=3.                                                         •   Need for unplanned treatment break not influenced
                                                                                                                                 by peg.
                                                                                                                             •   31% of control group went on to have a peg during
                                                                                                                                 or post treatment. – these pts lost large amt of wt.
                                                                                                                             •   Peg had no influence on overall survival or local
                                                                                                                                 control.
                                                                                                                             •   State that it can be difficult to educate the pt during
                                                                                                                                 XRT.
                                                                                                                             •   Complications in 6% (n=3): peritonitis, seeding,
                                                                                                                                 pneumoperitonium.


Senft M, Fietkau R, Iro H, Sailer D, Sauer     III-2 –   Cohort study. N=212          QOL tool compared 28 pts with early    At 6/52: Significant difference in QOL of oral nutrition      Probable bias d/t poor
R. The influence of supportive nutritional               head and neck cancer pts.    PEG vs. 81 pts with no PEG.            vs. PEG especially wrt domains of work, appetite and          response rate to QOL
therapy via percutaneous endoscopically                  22% (n=47) received a                                               strength, but not pain and satisfaction (p=0.038).            questionnaire (only 60%).
                                                         PEG within 2/52 after
guided gastrostomy on the quality of life of
                                                         XRT started.
cancer patients. Support Care Cancer                     63% (n=134) no PEG,
1993;1:272-5.                                            15% late PEG: (results not
                                                         analysed).
Citation                                       Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                    Comments
                                               Quality
Seven H, Calis AB, Turgut S. A randomized      II +      RCT, Turkey                 Intervention group (n=32): Early oral   Time to resumption of a regular solid diet (p<0.01):       Possible benefit to patient’s
controlled trial of early oral feeding in                                            feeding - clear fluids 24 h post op,    Early: 2.9 d ± 1.1 d; Late: 7.8 d ± 0.6 d                  QOL to resume regular solid
laryngectomized patients. Laryngoscope                   N=65                        then upgrade to regular diet as                                                                    diet.
                                                                                     tolerated.                              LOS in pts without fistula (NS):
2003;113:1076-9.
                                                         Patients who underwent                                              Early: 7.4 d ± 3.2 d; Late: 8.2 d ± 2.8 d
                                                         total laryngectomy with     Control group (n=33): Late oral
                                                         primary closure for a       feeding – EN via TOP catheter until     LOS in pts with fistula (NS):
                                                         malignant tumor involving   day 7 post op, then start oral diet.    Early: 26 days; Late: 29 days
                                                         the larynx and who were
                                                         candidates for primary      Outcomes:                               Fistula rate (NS):
                                                         voice restoration.          • Fistulas                              Early: n=2 (6.2%); Late: n=3 (9%)
                                                                                     • LOS


Shand AG, Wild SR, Grieve DC, Evans J,         IV Ø      Case series, UK             Radiological gastrostomy insertion      •   Success in 9/10, failure in 1/10 (unable to pass NGT   Radiological group more
Pendlebury J, Ghosh S. Radiological                                                  by push method & f/up for up to 6           – therefore had surgically placed gastrostomy).        likely to have advanced
insertion of gastrostomy in patients in whom             N=10 (neuro-deg disease     months post placement.                  •   Complications reported: pain at gastrostomy site in    disease (as per high mortality
                                                         (2), oesophageal ca (2),                                                10/10 (4 requiring opiates on d/c), 1x wound           rate at 6m).
endoscopy was unsuccessful. Dig Liver Dis
                                                         H&N ca (6)                  Outcomes:                                   infection.
2002;34:298-301.                                                                     • Complications                                                                                    Complications not defined.
                                                                                                                             •   No procedure-related deaths.
                                                         Patients who had a failed   • Mortality                             •   30 day mortality rate of all causes = 20% (only 1
                                                         PEG tube and progressed                                                 patient still alive at 6 months).                      Small sample size.
                                                         to radiological
                                                         gastrostomy insertion                                                                                                          QOL not measured but
                                                         (n=10/100).                                                                                                                    reported on.


Shike M, Berner YN, Gerdes H, et al.           IV -      Case series, USA            Long term feeding tube (PEG / PEJ).     Length of enteral nutrition support and weight             •   Difficult to interpret
Percutaneous endoscopic gastrostomy and                                                                                      changes in patients:                                           information when using
jejunostomy for long-term feeding in                     N=42                        PEG: n=36, received bolus feeding       No residual tumour, n=7:                                       evidence sheet as
patients with cancer of the head and neck.                                           PEJ: n=3, 8-10 hrs overnight            • N=6/7 with HETF for 497 +/- 340 days                         information not present.
                                                         Patients with malignant     Excluded: n=3 (unable to place tube)    • N=1 died due to other causes                             •   Unable to interpret
Otolaryngol Head Neck Surg 1989;101:549-                 disease of the Head and                                             • 3.9+/- 1.3kg mean weight gain                                nutrition data as no
54.                                                      Neck who had dysphagia.     Outcomes:                                                                                              baseline nutrition
                                                                                     • Length of enteral nutrition           Receiving further antineoplastic therapy, n=19:                information to gage if
                                                                                         support (days) and weight           • N=11/19 with HETF for 73+/-68 days with 4.0+/-               weight change > or < 5
                                                                                         change (kg)                            3.1kg                                                       or 10% over 1 or 6
                                                                                     • Complications post tube               • N=8/19 with indefinite HETF for 151+/- 89                    months.
                                                                                         insertion                                                                                      •   Shame they didn’t show
                                                                                     • Morbidity of home enteral             Advanced disease, n=13:                                        tumour staging and
                                                                                         nutrition                           • N=13 with HETF for 60+/-53                                   treatment modality by
                                                                                                                                                                                            site to interpret the data
                                                                                                                             Complications post Tube placement, n=3:                        on tumour site and
                                                                                                                             • Local infection treated with antibiotics                     number of days for
                                                                                                                                                                                            enteral nutrition.
                                                                                                                             Morbidity of HETF, n=4:
                                                                                                                             • N=1, Aspiration pneumonia treated with antibiotics
                                                                                                                             • N=1, Blocked tube successfully unblocked
                                                                                                                             • N=2, Local irritation which resolved
Citation                                       Level &   Study Design & Sample          Intervention & Outcomes                   Results                                                    Comments
                                               Quality
Shiley SG, Hargunani CA, Skoner JM,            IV Ø      Case series, USA               G-tube placement (before or during        Mean duration of G-tube placement before removal =         Small sample size.
Holland JM, Wax MK. Swallowing function                                                 chemoradiation) = 22 (81%).               6.2 (±5.7) months.                                         Retrospective design.
after chemoradiation for advanced stage                  N=27                                                                                                                                Did not statistically compare
                                                                                        Mean length of follow up 23.2             3, 6 months after treatment and most recent follow up:     to surgical group.
oropharyngeal cancer. Otolaryngol Head
                                                         Sequential or concurrent       months (range 3.2-72.8).                      33%, 50%, 48.2% respectively had exclusively oral
Neck Surg 2006;134:455-9.                                chemoradiation for stage                                                     diet
                                                         III/IV disease for             Retrospective review of swallowing            44.5%, 29.2%, 37% respectively had tube feeds +
                                                         oropharyngeal cancer           function of 30 patients’                      oral intake
                                                         were identified.               hospital/clinic charts after sequential       22%, 20.8%, 14.8% respectively had tube feed only
                                                                                        or concurrent chemoradiation for
                                                                                        stage III/IV OPC, and then                After 1 year, of the 13 patients with no recurrence, all
                                                                                        comparing results to patients treated     were able to eat orally. 4 of these (31%) had some oral
                                                                                        surgically (for similar tumours).         intake but still required tube feeds.

                                                                                        Outcomes:                                 Higher rate of G-tube dependence in BOT vs. tonsil
                                                                                        Swallowing function (outcome based        lesion (67% vs. 25%, p=0.049) no longer significant
                                                                                        on G-tube dependence)                     when patients with recurrence were excluded (50% vs.
                                                                                             No oral intake                       17%, p=0.18).
                                                                                             Some oral intake but still
                                                                                             requiring tube feeds                 No association between age or tumour stage and the rate
                                                                                        100% oral intake with no tube feed        of G-tube dependence.
                                                                                        requirements.


Shirodkar M, Mohandas KM. Subjective           IV Ø      ?, India                       Patients’ nutritional status assessed     Adverse events occurred in 33 (12.4%) patients after       Researchers modified the
global assessment: a simple and reliable                                                using modified SGA and BMI. Day           surgery. The frequencies of adverse events in SGA          SGA based on difficulty of
screening tool for malnutrition among                    N=294                          1-3 pre op.                               groups A, B and C were 12/152 (7.9%), 17/98 (17.3%)        Indians recalling usual body
                                                                                                                                  and 4/16 (25%) respectively (p= 0.025).                    weight.
Indians. Indian J Gastroenterol 2005;24:246-
                                                         Patients admitted for          Outcomes:                                 The frequency of adverse events in the three BMI groups
50.                                                      elective cancer surgery.           Adverse events                        were 12/103 (11.7%), 9/53 (17.0%) and 12/110 (10.9%)       Limited use of this article.
                                                         Cancer site included H+N           Duration antibiotic use               respectively (p= 0.522).                                   It is not specific to Head and
                                                         (42%), GIT, breast,                Post op hospital stay                                                                            Neck.
                                                         thorax, genitor-urinary            30-day mortality                      The odds ratio for the association of malnutrition with
                                                         tract, bone and soft tissue.                                             adverse events was 2.89% (95% CI 1.25 – 6.67) for          ? validity of modified SGA.
                                                                                                                                  SGA-B and 5.27 (1.35-20.51) for SGA-C compared with
                                                                                                                                  SGA-A.
                                                                                                                                  The odds ratio of the association of adverse events and
                                                                                                                                  BMI was 1.25 (95% CI 0.47-3.30) and 0.56 (0.22-1.43)
                                                                                                                                  for BMI <18.5 and BMI 18.5 – 20 kg/m2 respectively,
                                                                                                                                  as compared to BMI >20.0kg/m2.

                                                                                                                                  Four patients died, all deaths occurred in patients with
                                                                                                                                  SGA-B or C scores.
                                                                                                                                  Prolonged LOS for each of the cancer sites was
                                                                                                                                  significantly higher with increasing malnutrition as
                                                                                                                                  determined by SGA scores.
                                                                                                                                  The SGA scores for patients with cancer of the head and
                                                                                                                                  neck, thorax and GI tract cancers were:
                                                                                                                                  A: 99/152 (65.1%)
                                                                                                                                  B: 78/98 (79.6%)
                                                                                                                                  C: 16/16 (100%)
Citation                                          Level &   Study Design & Sample        Intervention & Outcomes                  Results                                                   Comments
                                                  Quality
Silander E et al. The use of prophylactic         IV Ø      Prospective case series,     PEG placement                                Ave use of PEG was 30 days after treatment started        1 of a few studies that
percutaneous endoscopic gastrostomy and                     Sweden                                                                    and average 180 days use in total.                        exist that looked at
early enteral feeding in pateitns with                                                   Time points:                                 89% pts had returned to normal diet after 1 yr.           multiple nutritional
                                                            N=64                         Inclusion and 1, 2, 3, 6, 12 and 24          42% pts had lost weight from inclusion (on average        parameters i.e. wt, BMI,
advanced head and neck cancer - a
                                                                                         months after start of treatment.             6% body wt).                                              FFM etc.
prospective longitudinal study. The                         Newly diagnosed                                                           Ongoing LOW despite nutritional advice/early tube         Well written study.
european e-journal of clinical nutrition and                untreated oral, pharyngeal   Outcomes:                                    feeding i.e. after 6 months 62% were malnourished
metabolism 2010,                                            cancer or neck lymph         Wt, BMI, body composition, FFMI,             (defined as loss of ≥10% wt) and on average 11.2%     Unclear where data was
doi:10.1016/j.eclnm.2010.04.002.                            node metastases with         dysphagia and use of tube feeding            body wt however BMI & FFM remained normal.            collected (hospital, multi-
                                                            unknown primary in stage     were all examined.                                                                                 site?).
                                                            III or IV considered for
                                                            curative treatment.
Silver H. Changes in body mass, energy            IV Ø      Prospective case series,     Specific nutrition interventions were    •   Wt loss began 1 week after CCR began (significant     •   Small sample
balance, physical function, and                             USA                          individualised for increasing energy,        decline from baseline).                               •   Test/measurement types
inflammatory state in patients with locally                                              protein where needed – oral nutrition    •   LBD accounted for 71.7%+/-21% of body mass loss.          clearly stated and valid,
                                                            N=17                         supps when intake <75% daily goals.      •   No change occurred in energy intakes or                   good range used to
advanced head and neck cancer treated with
                                                                                                                                      calorie/nitrogen ratio.                                   measure nutritional status
concurrent chemoradition after low-dose                     Pts with stage III or IV     Outcomes:                                •   REE was significant increased when adjusted for
induction chemotherapy. Head and neck -                     H&N ca (SCC of oral          Body mass, energy balance, physical                                                                Only 2 time points for
                                                                                                                                      LBM loss (p=.019).
journal for the sciences and specialties of the             cavity, oropharynx,          function, and inflammatory state.        •   LBM loss was significant associated with physical     measurements – may have
head and neck 2007;29:893-900.                              hypopharynx, larynx)                                                      performance decline (r=.71, p=.004) and increased     had further changes in
                                                            treated with 9 wks low       Time points:                                 functional dependence (r.58, p=.02).                  measures beyond this time.
                                                            dose induction chemo 2       Baseline (2 wks before CCR), 1           •   Cytokine levels were strongly associated with
                                                            wks prior to ~7 wks CCR.     month post CCR.                              physical and functional decline.

Silverman JE, Weber CW, Silverman S, Jr.,         II Ø      RCT double-blind, USA        1.   Zn 18mg capsules 4 times daily      Weight – no difference.                                   An RCT, however the brevity
Coulthard SL, Manning MR. Zinc                                                                during treatment                                                                              of the paper, and the limited
supplementation and taste in head and neck                  N=19                          2. Lactose placebo.                     Serum zinc – significant increase in intervention group   detail of some descriptions
                                                                                         Assessments conducted at baseline        by the end of radiotherapy. No correlation between Zn     may compromise the quality
cancer patients undergoing radiation
                                                            Head and neck patients       and then weekly during radiotherapy.     levels and stage of disease or taste perception.          rating.
therapy. J Oral Med 1983;38:14-6.                           who were to receive          All patients were given a printed
                                                            radiotherapy which           handout as well as verbal suggestions    Dysgeusia - Was not related to body weight status,        Limited information on
                                                            included major salivary      for dietary intake in order to           serum Zn levels. RT induced taste changes occurred        statistical analyses, p values
                                                            glands and taste bud areas   maximally support their nutritional      during the 1st third of treatment.                        not reported.
                                                            in treatment field.          state during treatment.
                                                                                                                                  3 weeks post RT – Appeared to be a more rapid             Small sample.
                                                                                         Outcomes: Weight loss, serum Zn          improvement in the Zn supplemented group (64% in exp
                                                                                         changes, dysgeusia, taste preservation   group vs. 22% in control group reporting definite         Limited results for nutritional
                                                                                         or enhancements.                         improved taste perception).                               related end-points.
Siroen MPC, van Bokhorst-de van der               III-2 Ø   Comparative study,           Post-op enteral nutrition (~150%         In the malnourished group:                                Head and Neck surgery is
Schueren MAE, Richir MC, et al. The                         Amsterdam                    BEE, calculated by Harris Benedict       From pre surgery to day 1 post surgery,                   accompanied by a significant
prognostic value of severe malnutrition in                                               formula).                                rT3 increased p= 0.009                                    increase of rT3 and a
                                                            Malnourished n=16                                                     T3 decreased p= 0.001                                     significant decrease of T3
the development of nonthyroidal illness in
                                                            Well nourished n=6           Outcomes:                                T4 declined p= 0.001                                      and FT4 in malnourished
head and neck cancer patients. JPEN J                                                    Plasma levels of the thyroid             TSH no change NS                                          patients, indicating the
Parenter Enteral Nutr 2006;30:415-20.                       T1-T4 SCC of oral cavity,    hormones                                 From day one to day four and day seven post op            development of non thyroidal
                                                            larynx, oropharynx, or       Pre op, day 1,4,7 post op.               • rT3 no change day 1 to 4 NS                             illness (NTI) in these
                                                            hypopharynx and                                                       • rT3 higher on day 4 compared to baseline p=0.002        patients. None of the well
                                                            underwent major head and                                              • rT3 no change on day 7 compared to baseline NS          fed patients developed NTI.
                                                            neck surgery of curative                                              • T3 increase day 1 to 4 p=0.01
                                                            intent.                                                               • FT4 increase days 1 to 4 p=0.002
                                                                                                                                  • T3 and FT4 no change between day 4 and 7 NS
                                                                                                                                  In well nourished patients:
                                                                                                                                  No changes T3 and FT4 at any time point
Citation                                       Level &   Study Design & Sample         Intervention & Outcomes                Results                                                      Comments
                                               Quality
Smith A, Chandu A. Percutaneous                IV Ø      Case series, Australia        Outcomes:                              n=5 PEG pre op                                               ? Reliability of BMI to assess
endoscopic gastrostomy for patients                                                    • Time and type of PEG placed          n=27 PEG peri op                                             nutritional status.
undergoing resection of oral tumours. Ann R              N=33                          • Duration of PEG feeding              n=2 PEG post op
                                                                                       • Complications                                                                                     No discussion on the effect of
Australas Coll Dent Surg 2000;15:349-51.
                                                         Patients who had a            • Weight/BMI                           Mean time to PEG removal was 126 days.                       the effects of radiation
                                                         resection for oral tumours                                           •   N=23 removed & no evidence of disease                    therapy on the 20 patients and
                                                         had a PEG tube inserted                                              •   N=5 died with their PEG in place                         possible link to prolonged
                                                         1992-2000.                                                           •   N=5 still using PEG with no evidence of disease          tube feeding.
                                                                                                                                  (mean use 369 days)
                                                                                                                                                                                           There was no comparison of
                                                                                                                              Major complications n=2, minor complications n=4             weight and BMI to previous
                                                                                                                              Patients with greater initial weight lost more weight        reported studies as discussed
                                                                                                                              p=0.063                                                      in the aim of the paper.
                                                                                                                              0-2 week mean weight loss of 3.4% p=0.02
                                                                                                                              0-8 weeks mean weight loss of 3.6% p=.009
                                                                                                                              2-8 weeks mean weight gain 1% NS
                                                                                                                              Change in BMI – NS


Snyderman CH, Kachman K, Molseed L, et         II +      RCT – double blind            Peri op EN:                            Infections Group IN = 25% STD = 41% (P<0.02)                 33 pts had protocol
al. Reduced postoperative infections with an             USA (2 centres)                1. Pre/post IN or post IN (n=82)                                                                   violations.
immune-enhancing nutritional supplement.                                                2. Pre/post std or post std (n=47)    Wound healing IN = 14% STD = 15% (NS)
                                                         N=136                                                                                                                             Started as 4 groups but then
Laryngoscope 1999;109:915-21.
                                                                                       Outcomes: Pre op and day 7 post op     Fistula IN = 5% STD = 2% (NS)                                collapsed to 2, so difficult to
                                                         Stage II-IV SCC oral          • Bloods, Infections,                                                                               tell effect of pre or post IN.
                                                         cavity, pharynx, larynx for       Complications, LOS                 ICU days IN = 7.2 days STD =10 days (NS)
                                                         curative surgery.
                                                                                                                              LOS IN = 15.3 days STD = 17.4 days (NS)

                                                                                                                              Albumin IN = 3.12g/dL STD = 2.94g/dL (P=0.05)


Sorensen D, McCarthy M, Baumgartner B,         II Ø      RCT – blinded, USA            Peri op EN (Pre 7 days and post op 7   Plasma proteins – Reduced in both groups on day of           Pilot study – demonstrates
Demars S. Perioperative immunonutrition in                                             days) via tube or oral – 1L per day    surgery, and day 1 and 4 post op.                            feasibility but not statistical
head and neck cancer. Laryngoscope                       N=15                          1. IN (n=8)                                                                                         power.
                                                                                       2. Std (n=7)                           Immune function: CRP reduced in IN group d 1 post op
2009;119:1358-64.
                                                         SCC HNC with curative                                                (p=0.03).                                                    No declaration of funding –
                                                         surgery.                      Outcomes: Baseline and day 1,4,8                                                                    using Novartis product.
                                                                                       post op                                Wound complications:
                                                                                       • Bloods, Immune function,             Major - IN = 37.5% STD = 28.5%                               Difficult to tell the effect of
                                                                                            Wound complications               Minor - IN = 87.5% STD = 71.5%                               pre or post IN.


Stableforth WD, Thomas S, Lewis SJ. A          I+        Systematic review             Immunonutrition                        No significant impact on wound infections, fistulas,         Small studies with varying
systematic review of the role of                                                                                              QOL, mortality or immune parameters.                         study design.
immunonutrition in patients undergoing                   N=10 RCT
                                                                                                                              Significant reduction in length of stay 3.5 days (P<0.05).
surgery for head and neck cancer.
                                                         Patients receiving peri-
International Journal of Oral and                        operative                                                            More studies required to substantiate the benefit as
Maxillofacial Surgery 2009;38:103-10.                    immunonutrition.                                                     mechanism not clear.
Citation                                         Level &   Study Design & Sample        Intervention & Outcomes                Results                                                  Comments
                                                 Quality
Studer G, Peponi E, Kloeck S, Dossenbach         IV Ø      Case series                  Intervention: IMRT                     Mean follow up 26 months.                                Details of PEG insertion
T, Huber G, Glanzmann C. Surviving                                                                                                                                                      criteria not stated.
hypopharynx-larynx carcinoma in the era of                 Zurich, Switzerland          Outcomes: 2yr local, nodal and loco-   Hypopharynx (n=65), supraglottic (n=31), glottis
                                                           March 2002-Dec 2008          regional control (LRC), disease free   (n=27):
IMRT. International Journal of Radiation
                                                                                        rates and overall survival.            • PEG dependence (>2yrs) n=3, 0, 0 respectively
Oncology, Biology, Physics 2010;77:1391-                   N=123                                                               • LRC 88%, 80%, 83% respectively
6.
                                                           T1-4 SCC hypopharynx                                                Rates:
                                                           (n=65), supraglottic                                                • 2yr local nodal = 82%
                                                           (n=31), glottis (n=27)                                              • Nodal = 90%
                                                           undergoing IMRT (+86%                                               • Loco-regional control (LRC) = 77%
                                                           had concurrent chemo)                                               • Distant control rate = 90%
                                                            - Post-op IMRT
                                                                                                                               • Disease free rates = 75%
                                                                excluded
                                                                                                                               • Overall survival = 83%
                                                           Aim: cf. results of IMRT
                                                                                                                               PEG insertion n= 36 (29%) before or during IMRT and 8
                                                           methods at centre to
                                                                                                                               (22%) PEG dependent at 12 months.
                                                           published results.



Taller A, Horvath E, Ilias L, et al. Technical   IV Ø      277 patients with head and                                          In 10% of patients the standard endoscopic placement     Does not comment on
modifications for improving the success rate               neck cancer with                                                    was not successful: 4/27 trismus, therefore use          training of staff who insert
of PEG tube placement in patients with head                oropharyngeal dysphagia                                             transnasal access, 9/27 obstruction of upper aero        PEG’s.
                                                           requiring PEG placement.                                            digestive tract: used straight laryngoscope, 12/27 d/t
and neck cancer. Gastrointest Endosc
                                                                                                                               oesophageal obstruction.
2001;54:633-6.
                                                                                                                               99% success rate overall
                                                                                                                               Only 2 had failed PEG placement. Due to total
                                                                                                                               oropharyngeal obstruction caused by advanced,
                                                                                                                               incurable Ca.
                                                                                                                               • No complications with any placement within 30 days
                                                                                                                                   and no seeding.



Talmi YP, Bercovici M, Waller A, Horowitz        III-2 Ø   Retrospective Cohort         Comparison of home based (n=24)        Presence of feeding tube (PEG/J).                        Physician/patients choice for
Z, Adunski A, Kronenberg J. Home and                       study, Israel                vs. hospital based (n=102) hospice     Home 33% (n=8/24) vs. Hospital 33% (n=34/102).           preferred hospice program –
inpatient hospice care of terminal head and                                             program.                               Mod-severe wt loss of >10%.                              bias and groups not
                                                           N=126                                                               Home 63% (n=15/24) vs. Hospital 59% (n=60/102).          comparable at baseline –
neck cancer patients. J Palliat Care
                                                                                        Outcomes:                              Symptoms (pain):                                         hospital pts tended to have
1997;13:9-14. e                                            Terminal HNC pts             • Symptoms                             Home 70% vs. Hospital 80%                                more pts with >15% wt loss,
                                                                                        • Nutrition                                                                                     home pts tended to be
                                                                                                                                                                                        younger.
Citation                                       Level &   Study Design & Sample       Intervention & Outcomes                  Results                                                   Comments
                                               Quality
Trotti A, Bellm LA, Epstein JB, et al.         I+        Systematic review of RCT    RCTs with at least 10 patients           Mucositis:                                                Literature sparse for
Mucositis incidence, severity and associated                                         reporting incidence of                   Mean incidence – 80%                                      hospitalisations (5), feed tube
outcomes in patients with head and neck                  N=33 studies                mucositis/stomatitis and at least 1      Mean incidence of Grade III-IV mucositis – 39%            placements (1), oral pain,
                                                                                     outcome of interest.                     Mean duration of mucositis 39.7 days (7-98 days)          dehydration, dysphagia,
cancer receiving radiotherapy with or
                                                         N=6181 patients                                                      Frequency of grade III-IV mucositis:                      opioid use, QoL.
without chemotherapy: a systematic                                                   Radiotherapy with or without             • 57% RT-AF                                               Correlations – limited by
literature review. Radiother Oncol                       Patients receiving RT for   chemotherapy including conventional      • 34% in RT-conventional                                  small size of many studies,
2003;66:253-62.                                          head and neck cancer.       RT, altered fractionation RT,            • 43% in RT+CT                                            should be interpreted with
                                                                                     RT+CT, surgery (either pre or post       Frequency of mucositis was lowest in those receiving      caution (studies report biases
                                                                                     RT/CT).                                  CT alone – none with grade III-IV.                        and confounding factors).
                                                                                                                              Rates of hospitalisation due to mucositis: overall 16%    Some relevant RCTs not
                                                                                     Mucositis prevention/treatment -         (n=700), in RT-AF 32%.                                    included.
                                                                                     sucrulfate, antibiotics lozenges,        Interruptions or modifications to RT regimens due to
                                                                                     amifostine, low energy laser,            mucositis (n=1267) 11%.                                   Majority of studies reported
                                                                                     povidone iodine, biperiden +                                                                       mucositis incidence as an
                                                                                     pilocarpine.                             Weight:                                                   ancillary outcome, 9 were
                                                                                                                              10/33 studies reported on mean weight losses mean         RCTs specifically studying
                                                                                     Outcomes:                                loss range 3.0-6.7kg (6-12% LOW).                         mucositis interventions.
                                                                                     Pain, dysphagia, weight loss,            8/33 studies (n=880) reported incidence of weight loss:   15/33 studies considered
                                                                                     interruption and modifications to        34% of patients lost weight, 17% lost ≥10%.               adequately powered (level of
                                                                                     treatment (RT or CT), hospitalisation,   Strong +ve correlation between: mucositis and patients    evidence I), median quality
                                                                                     incidence of insertion of feeding        with weight loss (8 treatment arms: r=0.83, p=0.001).     score in these studies only 2,
                                                                                     tubes, opioid use, QoL, tumour                                                                     mean 2.7 implies
                                                                                     response, survival.                      TF feeding:                                               questionable internal validity.
                                                                                                                              Feeding tube insertion – 5 studies (n=819): Mean
                                                                                                                              frequency 19%.                                            Overall, a well designed
                                                                                                                              Strong +ve correlation between:                           systematic review, however
                                                                                                                              • Grade III-IV and requiring feeding tubes (8             limited by the above.
                                                                                                                                  treatment arms: r=0.88, p=0.004).
                                                                                                                              Mucositis intervention studies:
                                                                                                                              • 4/139 in placebo required feeding tube insertion due
                                                                                                                                  to mucositis vs. 0/139 in intervention group.
Citation                                    Level &   Study Design & Sample        Intervention & Outcomes                 Results                                                     Comments
                                            Quality
Tsao AS, Garden AS, Kies MS, et al. Phase   IV Ø      Post hoc anlysis, USA        A Phase I/II trial: 2 arms receiving    Phase I:                                                    Assessing acute and late
I/II Study of Docetaxel, Cisplatin, and                                            different schedules of docetaxel and    • Arm 2 - 60% prolonged severe mucositis, 100%              toxicities, including
Concomitant Boost Radiation for Locally               N=52                         Cisplatin, both with concomitant           grade 3 skin toxicity, dose level 0 was above the        swallowing function and
                                                                                   boost radiation. Patients were             MTD, 1 patient required withholding of week 4            feeding tube dependence
Advanced Squamous Cell Cancer of the
                                                      Patients with stage III-IV   observed during and post treatment         chemo due to declined performance status.                were considered additional
Head and Neck. J Clin Oncol 2006;24:4163-             HNSCC.                       for toxicities to determine Max                                                                     objectives of the study not
                                                                                                                           • Arm 1 - 29% prolonged severe mucositis, all 14 had
9.                                                                                 Tolerable Dose and 3-6 monthly up          grade 2-3 skin toxicity, all patients completed          primary objectives.
                                                                                   to 5 years post treatment for control      therapy without interruption or delay due to toxicity.
                                                                                   rates, response rates survival.         • DLT was defined as prolonged severe mucositis and         Comparisons across trials -
                                                                                                                              MTD as initial dose level arm 1 dose level 0             variability in patient
                                                                                   Outcomes:                                  studied in phase II.                                     eligibility and selection.
                                                                                   Primary: 2 year locoregional control
                                                                                   rate.                                   Phase II:
                                                                                   Secondary: Response rate,               Acute toxicities:
                                                                                   progression-free survival (PFS) and     • Grade 3 mucositis in 81%
                                                                                   overall survival (OS).                  • Grade 3 skin toxicity in 44%
                                                                                                                           • Grade 2 fatigue in 44%
                                                                                   Additional objectives: acute and late   • Grade 3 weight loss in 12%
                                                                                   toxicities (including swallowing        • Grade 3 dysphagia in 33%
                                                                                   function and feeding tube               • Prolonged mucositis (grade 3 or higher at 6 weeks
                                                                                   dependence).                                post treatment) in 36%
                                                                                                                           • Feeding tube placement during treatment in 79%
                                                                                                                           • Feeding tube before or at start of treatment in 17%
                                                                                                                           • Feeding tube during or right after concurrent therapy
                                                                                                                               in 62%
                                                                                                                           • 1 treatment related death after treatment completion
                                                                                                                           Late toxicities:
                                                                                                                           • 8 (25%) out of 32 patients who had evidence of
                                                                                                                               disease at 2 years were feeding tube dependent. As
                                                                                                                               of June 06, 5 (17%) out of 29 alive and NED are
                                                                                                                               tube dependent.
                                                                                                                           • Tracheostomy dependence post treatment in 3
                                                                                                                               patients.
                                                                                                                           • 2 year locoregional control rate: 71% (95% CI, 59 to
                                                                                                                               85)
                                                                                                                           • 2 year progression-free survival rates: 61% (95% CI,
                                                                                                                               49 to 77)
                                                                                                                           • 2 year overall survival: 65% (95% CI, 53 to 80)
                                                                                                                           • Median survival: 37.8 months
                                                                                                                           Comparisons with other trials:
                                                                                                                           • Chemotherapy combined with concomitant boost
                                                                                                                               fractionation (as opposed to taxane-containing
                                                                                                                               regimen) explains the relatively high incidence of
                                                                                                                               long-term feeding tube dependence in this study.
                                                                                                                           • Weekly Cisplatin and paclitaxel with conventional
                                                                                                                               fractionation – 6% rate of long-term feeding tube in
                                                                                                                               disease-free survivors.
                                                                                                                           • Concurrent carboplatin/fluorouracil – 51% long-term
                                                                                                                               feeding tube dependence vs. 25% in concomitant
                                                                                                                               boost radiation alone.
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                 Results                                                    Comments
                                               Quality
Tucker AT, Gourin CG, Ghegan MD,               III-2 Ø   Comparative cohort, USA      3 month min follow-up. Compared:        Minor complications = Cellulitis, leakage (most            No statistical difference wrt
Porubsky ES, Martindale RG, Terris DJ.                                                Push versus pull PEG.                   common), ileus tube obstruction, gastric wall              stage and site i.e. groups are
'Push' versus 'pull' percutaneous endoscopic             Retrospective case series:                                           haematoma. 22% “pull” vs. 0% “push” technique              comparable.
                                                         pts with SCC head and        Outcomes:                               (p=0.03).
gastrostomy tube placement in patients with
                                                         neck attending medical       • Overall complication rate             Major complications = Necrosis (1), peritonitis, sepsis,   Not enough discussion re
advanced head and neck cancer.                           College of Georgia                                                   intra-abdo abscess (2), fistula, aspiration, PEG site      choice and diff of pts
                                                                                      • Minor complication rate
Laryngoscope 2003;113:1898-902.                          undergoing CRT/ hyper            (cellulitis, ileus, peristomal      metastasis (1): 8% “pull” vs. 0% “push” technique.         treatment effect on
                                                         fractionation/ in those in       leakage, extrusion, tube            Current practice is to recommend PEG in those with         gastrostomy tube choice –
                                                         whom surgery is likely to        obstruction, gastric wall           significant wt loss.                                       may have affected
                                                         cause prolonged recovery.        haematoma)                          2 groups: push n=29 & pull n=50                            complication rate results -
                                                                                      • Major complication rate (sepsis,      More pts had push PEG compared to pull PEG                 largest % had CRT for push
                                                         N=79. Push method                peritonitis, intra-abdo abscess,    (p<.0001).                                                 technique and operative
                                                         N=29, pull (Pansy) N=50          haemorrhage, gastrocolic fistula,   Overall complication 19% (15/79 pts).                      treatment for pull technique.
                                                                                          visceral perforation, aspiration,   Overall complication in push 0% (0/29) & overall
                                                                                          PEG site metastasis)                complication in pull 30% (15/50) = p value .0006.
                                                                                                                              Overall minor complication 11/79, 14% (0/29, 0% push;
                                                                                                                              11/50, 22% pull; p = 0.03).
                                                                                                                              Overall major complication 4/79, 5% (0/0, 0% push;
                                                                                                                              4/50, 8% pull) – not stat significant diff.

                                                                                                                              1x pt had PEG site metastasis (pull PEG).
                                                                                                                              Mean duration of PEG use = 8 months (range 3 wk - 30
                                                                                                                              months).
                                                                                                                              No pt required hospitalisation for treatment of
                                                                                                                              dysphagia, aspiration or dehydration.
                                                                                                                              Mean follow-up of pts was 11 months (range 3-24
                                                                                                                              months), no difference btw grps.
Turaka A, Li T, Nicolaou N, et al. Use of a    III-3 Ø   Retrospective comparative    Intervention: Standard low neck             n= 37 low neck field (LNF)                             N= 52 (57%) rx with various
conventional low neck field (LNF) and                    study                        field (LNF) or IMRT without LNF to          30% had PEG                                            chemotherapies.
intensity-modulated radiotherapy (IMRT):                                              treat the low neck.
                                                         N=91                                                                     n= 54 IMRT without LNF                                 PEG criteria for insertion not
no clinical detriment of IMRT to an anterior
                                                            n= 37 low neck field      Outcomes:                                   29% had PEG (also stated 33%) – ns cf LNF group        discussed.
LNF during the treatment of head-and neck-                  (LNF)                         Time to failure
cancer. International Journal of Radiation                  n= 54 IMRT without            PEG use (used as a surrogate            3yr disease free survival
Oncology, Biology, Physics 2011;79:65-70.                   LNF                           marker of laryngeal oedema              87% LNF, 79% non-LNF (p=0.2)
                                                                                          causing aspiration)
                                                         H&N SCC undergoing                                                       3 yr local regional failure rate
                                                         curative intent RT +/-                                                   4% LNF, 21% non-LNF (p=0.04)
                                                         chemotherapy.
                                                                                                                                  Conclusion: LNF to treat low neck did not increase
                                                                                                                                  risk of regional failure or decrease PEG tube
                                                                                                                                  requirements.
Tyldesley S, Sheehan F, Munk P, et al. The     III-2 Ø   Matched case-control         Elective Pre-radiotherapy               Wt loss = 3% in elective G tube vs. 6% in control.         No selection criteria: depend
use of radiologically placed gastrostomy                 study.                       gastrostomy (n=12) vs. non-elective                                                                on individual oncologist.
tubes in head and neck cancer patients                                                (n=30).                                 Average wt loss at 4-6 weeks and 3/12 significantly        Small study, lacking power,
                                                                                                                              different (p=0.001, 3% tube fed verses 9% controls).       QOL and survival not
receiving radiotherapy. Int J Radiat Oncol
                                                                                                                                                                                         examined.
Biol Phys 1996;36:1205-9.                                                                                                     Length of Stay in elective peg = 4.9d, and non elective
                                                                                                                              peg 19d but results skewed by non-nutrition related
                                                                                                                              problems.

                                                                                                                              Average gastrostomy tube in situ 21 weeks in elective
                                                                                                                              patients. 97% success rate of G tube insertion.
Citation                                       Level &   Study Design & Sample         Intervention & Outcomes                   Results                                                     Comments
                                               Quality
Unsal D, Mentes B, Akmansu M, Uner A,          IV Ø      Case series, Turkey           Patients receiving RT were grouped        Malnutrition (SGA B or C) was present in 26% of all         Secondary endpoint (to assess
Oguz M, Pak Y. Evaluation of nutritional                                               according to tumour location and          patients referred to RT. This increased to 43% at the end   possible contributions of
status in cancer patients receiving                      N=200                         nutrition status was evaluated at         of RT (p<0.0001).                                           nutritional support to patients
                                                                                       regular intervals (before RT, end of                                                                  with severe malnutrition):
radiotherapy: a prospective study. Am J Clin
                                                         Adults with primary           RT and 3 and 6 months post RT).           •   The difference predominated in H+N patients             Improvement in nutritional
Oncol 2006;29:183-8.                                     cancer who received                                                         (p<0.0001)                                              status at 3 and 6 months post
                                                         outpatient primary or         Patients who were moderately              •   Malnutrition in H+N cancer increased from 24%           treatment likely associated
                                                         adjuvant RT (stage I-III).    malnourished were provided an                 (pre-RT) to 88% at the end of RT (p<0.0001)             with diminishing side effects
                                                                                       additional portion of a meal.             •   At onset, malnutrition was most often present in        (as well as provision of
                                                         N=34 were H&N cancer          Patients were provided standard               gastric ca patients (55%)                               nutritional support) – no
                                                                                       enteral feeding formula during and        •   Malnutrition was most often present: H+N at the end     comparisons made between
                                                                                       after the irradiation period as long as       of RT (88%)                                             nut support vs. no nutritional
                                                                                       they were in the severely                 •   At 6 month follow, only 8% of all patients were         support in this study.
                                                                                       malnourished group.                           malnourished
                                                                                                                                 •   Nutritional status of all groups improved at 6 months
                                                                                       Outcome:                                      (p<0.0001), except breast (no patients with severe
                                                                                       Nutrition status (SGA)                        malnutrition at any time)

Urban KG, Terris DJ. Percutaneous              IV Ø      Case series, USA              PEG insertion (‘pull’ technique)          •   Overall complication rate of PEG ‘pull’ technique       Expert opinion: PEG
endoscopic gastrostomy by head and neck                                                                                              7.3%                                                    insertion is convenient,
surgeons. Otolaryngol Head Neck Surg                     N=39                          Outcomes:                                 •   Minor Complication = 4.9% (intra-op tube                ambulatory and less time
                                                                                       Complications                                 replacement and minor skin irritation)                  consuming in the presence of
1997;116:489-92.
                                                         Pts having PEG insertion                                                •   Major Complication = 2.4%                               moderate-severe dysphagia.
                                                         within H&N service.                                                                                                                 High pt satisfaction. Can
                                                                                                                                 28% placed at time of HNC resections.                       place at panendoscopy in pts
                                                         Case series: all patients                                                                                                           with significant wt loss
                                                         having Ponsky pull - PEG                                                18% placed at panendoscopy staging.                         planned for chemo-
                                                         insertion for any reason at                                                                                                         radiotherapy, or surgery
                                                         Stanford hospital 1992-                                                 38% placed for severe post surgical dysphagia.              likely to cause dysphagia.
                                                         1995, n=39.
                                                                                                                                 15% placed for neurological dysfunction, often in           Contradictions for PEG
                                                                                                                                 conjunction with tracheostomy.                              insertion: inability to perform
                                                                                                                                                                                             upper endoscopy, inability to
                                                                                                                                 2% major complication rate (1 pt required tube change       transilluminate abdominal
                                                                                                                                 d/t chronic granulation and irritation of the tube site).   wall, ascites, coagulopathy,
                                                                                                                                                                                             intra-abdo infection.
                                                                                                                                 5% minor complication rate (site irritation).
                                                                                                                                                                                             Expert opinion presented.
                                                                                                                                                                                             Does not expand on benefits
                                                                                                                                                                                             of different timing of
                                                                                                                                                                                             placement.
van Bokhorst-de van der Schueren MAE,          IV Ø      Amsterdam                     No pre-op nutrition support.              Recent weight loss was predictive of major                  Malnutrition varied from
van Leeuwen PA, Sauerwein HP, Kuik DJ,                                                 Post-op nutrition support given to all    complications P=0.01.                                       20% - 67% depending on
Snow GB, Quak JJ. Assessment of                          N=64                          patients (EN of approx 150% BEE                                                                       parameter of malnutrition
malnutrition parameters in head and neck                                               calculated with Harris-Benedict).         •   Weight loss <10%: probability 1/8                       used.
                                                         N=44 untreated and N=20                                                 •   Weight loss 10 – 15%: probability 50/50
cancer and their relation to postoperative               recurrent disease post RT     Outcomes:                                 •   Weight loss > 15%: probability 7/9
complications. Head Neck 1997;19:419-25.                                               Postoperative complications: none,
                                                         T2-T4 SCC of the oral         minor, major or non-surgical-related.     Previous radiotherapy was not a risk factor for post-op
                                                         cavity, larynx,               % weight loss 6/12, %IBW                  complications. NS.
                                                         oropharynx, or                Nutritional Index, Serum albumin
                                                         hypopharynx for surgery.      Total Lymphocyte Count, Body fat
                                                                                       and LBM.
Citation                                      Level &   Study Design & Sample          Intervention & Outcomes                 Results                                                     Comments
                                              Quality
van Bokhorst-de van der Schueren MAE,         III-2 Ø   Comparative study with         N= 32 malnourished (>10% wt loss        HLA-DR expression on monocytes.                             Validity of nutrition
von Blomberg-van der Flier BM, Riezebos                 concurrent controls,           6/12)                                   Malnourished 7.0 vs. Well nourished 10.4 P<0.01.            assessments.
RK, et al. Differences in immune status                 Netherlands                    N= 34 well-nourished                    Controls 11.7 vs. malnourished 7.0 P<0.001.
                                                                                       N= 43 healthy controls                  Controls 11.7 vs. well nourished 10.4 NS.                   Lower HLA-DR expression
between well-nourished and malnourished
                                                        N=66                                                                                                                               may be an important
head and neck cancer patients. Clin Nutr                                               Day of panendoscopy – immune            CD14+ cells                                                 underlying factor related to
1998;17:107-11.                                         Patients who were eligible     parameters determined.                  • Increased in both of the patient groups compared to       the increased risk of infection
                                                        for surgery for advanced                                                 the healthy controls.                                     in malnourished patients.
                                                        H+N sc.
van Bokhorst-de van der Schueren MAE.         IV +      Prospective Cohort,            Pre op nutrition screening – includes   Overall survival 55%, Disease specific survival 61%.
The Impact of Nutritional Status on the                 Netherlands                    %wt loss in last 6/12, %IBW,            Reduced survival with:
Prognoses of patients with Advanced Head                                               albumin, lymphocytes, nutritional       • Increasing N stage P=0.0003
                                                        N=64                           index, BIA.                             • Surgical margins P=0.0009
and Neck Cancer. Cancer 1999;86:519-27.
                                                                                                                               • Major post op complications P=0.04
                                                        T2-T4 H&N cancer               Outcomes at 3yrs:                       Nutritional status had no impact on over survival NS.
                                                        treated with curative intent   • Overall survival                      Relative risks of reduced survival significant in males.
                                                        surgery + RT.                  • Disease specific survival             • Pre op wt loss>5% RR=43
                                                                                                                               • Wt loss and post op complications RR=77

van Bokhorst-de van der Schueren MAE,         III-2 Ø   Comparative, Amsterdam         Larger nutrition trial in which         Patients who died had lost more weight (16%) than
von Blomberg-van der Flier BM, Kuik DJ,                                                patients were given peri-operative      patients who had survived (12%) p=0.034.
et al. Survival of malnourished head and                N=49                           nutrition support.                      Predictor of major post op complications regardless of
                                                                                                                               nutrition regimen: p=0.06.
neck cancer patients can be predicted by
                                                        Survivors: 17                  Immune parameters:                        1) Tumour type
human leukocyte antigen-DR expression                   Deaths: 32                      • Baseline on admission                  2) HLA-DR expression on monocytes
and interleukin-6/tumor necrosis factor-                                                • Pre op – day 1                       Cause of death:
alpha response of the monocyte. JPEN J                  SCC of the oral cavity,         • Post op - days1, 4, 7                Recurrent disease n=18, 2nd primary cancer n=4, 30d
Parenter Enteral Nutr 2000;24:329-36.                   larynx, oropharynx or                                                  post op mortality n=3, other cancer/unknown n=7.
                                                        hypopharynx undergoing         Outcomes at min. 16 months:             There was no statistical association between the
                                                        curative surgery, with         Survival/death                          occurrence of major complications and long term
                                                        preoperative weight loss                                               survival.
                                                        of >10%.                                                               Survivors had less pre-op wt loss (12.4%) that those that
                                                                                                                               died (16.5%) p=0.034.
                                                                                                                               Better HLA-DR expression p=0.05
                                                                                                                               Higher ability to produce cytokines p=0.010

van Bokhorst-de van der Schueren MAE,         II Ø      RCT (blinded for groups I      Peri op EN (pre 7-10days and post op    Comparisons between group 1 and 2 from baseline to          Attrition n=31 (63%).
Langendoen SI, Vondeling H, Kuik DJ,                    and II), Netherlands           for minimum 14 days)                    before surgery noted improvements for:
Quak JJ, Van Leeuwen PA. Perioperative                                                  1. No pre op + std post op             Physical function p=0.05                                    Access to dietitian but not
                                                        N=49                            2. Pre and post op std                 Emotional function P=0.031                                  stated if used.
enteral nutrition and quality of life of
                                                                                        3. Pre and post op IN                  Symptom scale for dyspnea P=0.021
severely malnourished head and neck cancer              Malnourished (>10% wt                                                                                                              Pre op EN improves QOL,
patients: a randomized clinical trial. Clin             loss) H&N cancer pts           Outcomes:                               Comparisons between group 1 and 3 from baseline to          before surgery, but no
Nutr 2000;19:437-44.                                    undergoing surgery.            (baseline, day 1 pre op, d/c, 6/12)     before surgery for:                                         additional benefit of pre op
                                                                                       • QOL                                   Physical function NS                                        arg.
                                                                                                                               Emotional function NS
                                                                                                                               Symptom scale for dyspnea NS

                                                                                                                               Improvements for group 2 compared to group 3 from
                                                                                                                               baseline to 6 months
                                                                                                                               Cognitive functioning P=0.033
                                                                                                                               Appetite loss P=0.04
                                                                                                                               No improvements from day before surgery to 6 months.
Citation                                          Level &   Study Design & Sample        Intervention & Outcomes                   Results                                                     Comments
                                                  Quality
van Bokhorst-de van der Schueren MAE,             II Ø      RCT (blinded for groups I    Peri op EN (pre 7-10d and post op for     Anthropometry (wt, FFM, grip strength)(NS)                  Pre-op nutrition has no effect
Quak JJ, von Blomberg-van der Flier BM, et                  and II), Netherlands         minimum 14 d)                                                                                         on clinical outcomes,
al. Effect of perioperative nutrition, with and                                          1. no pre op + std post op                Biochemistry (albumin)(NS)                                  nutrition status, or immune
                                                            N=49                         2. pre and post op std                                                                                function.
without arginine supplementation, on
                                                                                         3. pre and post op IN                     Complications (NS)
nutritional status, immune function,                        Malnourished (>10% wt
postoperative morbidity, and survival in                    loss) H&N cancer pts         Outcomes: (baseline, day 1 pre op,        Survival – Better survival IN group (trend p=0.15)
severely malnourished head and neck cancer                  undergoing surgery.          post op days 1,4,7, at d/c and survival   Survivors had less pre-op wt loss (12.4%) that those that
patients. Am J Clin Nutr 2001;73:323-32.                                                 at 6/12)                                  died (16.5%) p=0.034
                                                                                         • Anthropometry, immune
                                                                                               markers
                                                                                         • Post op complications, survival




van den Berg MGA, Rasmussen-Conrad EL,            IV Ø      Prospective,                 Weight: At diagnosis,                     Baseline weight status:
Gwasara GM, Krabbe PFM, Naber AHJ,                          observational, Netherlands   commencement of treatment, post-          Weight stable = 34,
Merkx MA. A prospective study on weight                                                  treatment, beginning and end of early     Weight loss 5-10% = 13.
                                                            N=47                         revalidation, beginning and end of
loss and energy intake in patients with head
                                                                                         late revalidation.                        Baseline BMI:
and neck cancer, during diagnosis, treatment                Patients with stage II-IV                                              Underweight <18.5 = 6,
and revalidation. Clin Nutr 2006;25:765-72.                 tumours in oral cavity,      Energy Intake: FFQ at diagnosis, end      Normal 18.5-25 = 26,
                                                            oropharynx and               of treatment and end of late              Overweight >25 = 15.
                                                            hypopharynx undergoing       revalidation.
                                                            curative treatment.                                                    Weight change: Body weight decreased:
                                                                                                                                      During treatment p=0.001
                                                                                                                                      Early recovery period. p=0.03
                                                                                                                                   Most severe in CRT and less severe in surgery.

                                                                                                                                   Energy intake:
                                                                                                                                      EI decreased from baseline through treatment,
                                                                                                                                      followed by increase in EI during revalidation
                                                                                                                                      p=0.04.
                                                                                                                                      For all modes of treatment EI was between 30-40
                                                                                                                                      kcal/kg except for the CRT group (during treatment
                                                                                                                                      EI 19kcal/kg).
                                                                                                                                      Positive correlation between changes in EI and body
                                                                                                                                      weight from baseline through treatment p=0.01.
                                                                                                                                      No correlation during revalidation, where weight
                                                                                                                                      decreased despite an increase in EI.
Citation                                         Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                      Comments
                                                 Quality
van den Berg MGA, Rasmussen-Conrad EL,           IV Ø      Prognosis, retrospective,   Weight loss and QoL data were           QoL according to wt loss                                     Small sample.
van Nispen L, van Binsbergen JJ, Merkx                     Netherlands                 prospectively collected at diagnosis,   At baseline: 9/47 malnourished (19%)
MAW. A prospective study on malnutrition                                               end of treatment and 6 months post          Patients in the ≥10% wt loss group (compared with
                                                           N=47                        treatment, and then the group was           <10%) had significantly worse scores for cognitive
and quality of life in patients with head and
                                                                                       divided into: ≥10% loss of weight           functioning (p=0.05), fatigue (p=0.02), dyspnoea
neck cancer. Oral Oncol 2008;44:830-7.                     Patients with SCC of the    and <10% loss of weight (within 6           (p=0.01) and loss of appetite (p=0.02).
                                                           oral cavity, oropharynx,    months) cohorts and then compared.      End of treatment: 15/47 malnourished (32%)
                                                           hypopharynx.                                                            ≥10% wt loss group significantly worse for global
                                                                                       Unintended weight loss (≥10% over           QoL (p=0.01), fatigue (p=0.03), pain (p=0.04),
                                                                                       previous 6 months/ malnourished).           senses (p=0.05), sticky saliva (p=0.01), felt ill
                                                                                                                                   (p=0.01), coughing (p=0.02).
                                                                                       Outcome: QoL                            6 months post treatment: 5/47 malnourished (11%)
                                                                                                                                   ≥10% wt loss group significantly worse scores for
                                                                                                                                   global QoL (p=0.02), fatigue (p=0.02), nausea and
                                                                                                                                   vomiting (p=0.02), pain (p=0.01), social eating
                                                                                                                                   (p=0.04), dry mouth (p=0.03), sticky saliva (p=0.04).
                                                                                                                               QoL and treatment modalities:
                                                                                                                                   Clinically significant difference between treatment
                                                                                                                                   modalities surgery patients scored highest on QoL
                                                                                                                                   (indicate better outcome).
                                                                                                                                   Radiotherapy as single modality lowest.
                                                                                                                                   Treatment modality accounted for 10% of the
                                                                                                                                   variance for cognitive function and fatigue.
                                                                                                                               Wt and treatment modalities:
                                                                                                                                   During revalidation patients who had surgery gained
                                                                                                                                   wt within a range previous to diagnosis.
                                                                                                                                   Patients who had RT or combined treatment kept
                                                                                                                                   their unintended wt loss until end of treatment.
                                                                                                                                   Tumour stage explained the variance (10%) of
                                                                                                                                   unintended weight loss during treatment, and some
                                                                                                                                   functioning and symptoms scores at baseline, during
                                                                                                                                   treatment and at revalidation.
van den Berg MGA, Rasmussen-Conrad EL,           III-1 Ø   Pseudo-RCT                  Intervention:                           IDC vs. SC:                                                     Randomised by postcode.
Wei KH, Lintz-Luidens H, Kaanders                          The Netherlands             Dietitian provided Individual dietary       Significant decrease in weight loss 2/12 post Rx            Malnutrition defined as
JHAM, Merkx MAW. Comparison of the                                                     counselling (IDC) vs.                       (p=0.03).                                                   unintentional wt loss
                                                           IDC n=20                    Nurse provided Standard nutritional         Malnutrition decreased over time in IDC group but           >5% in 1/12 and/or >10%
effect of individual dietary counselling and
                                                           SC n=18                     counselling (SC)                            increased in pts with SC (p=0.02).                          in 6/12.
of standard nutritional care on weight loss in             No significant diff                                                                                                                 Methodology could be
patients with head and neck cancer                         between groups at           Outcomes:                               Conclusion:                                                     improved by use of
undergoing radiotherapy. British Journal of                baseline.                   Weight loss, BMI, malnutrition (5%      Early and intensive IDC by a dietitian produces                 validated malnutrition
Nutrition 2010;104:872-7.                                                              wt loss/month) before, during and       clinically relevant effects in terms of decreasing wt loss      assessment tool.
                                                           Curative Rx: RT, CRT,       after Rx.                               and malnutrition vs. SC in pts with HNC undergoing               Should also consider
                                                           PORT; T2-4; Oral cavity,                                            RT.                                                              other endpoints e.g. QoL,
                                                           oropharynx, hypopharynx.                                                                                                             LOS etc.
Vassilopoulos PP, Filopoulos E, Kelessis N,      IV -      Case series, Greece,        Surgical gastrostomy (modified          Surgical gastrostomy (modified Janeway) under local          Poor described methodology.
Gontikakis M, Plataniotis G. Competent                                                 Janeway) under local anaesthetic.       anaesthetic was successful in all cases, with no post-op
gastrostomy for patients with head and neck                N=24 (19 pts H&N Ca, 5                                              mortality, and wound infections in 4 patients.
                                                           pts upper GI)               Outcomes:
cancer. Support Care Cancer 1998;6:479-81.
                                                                                       Complications, length of stay,
                                                           Malnourished patients       survival.
                                                           with H&N and upper GI
                                                           Ca given surgical
                                                           gastrostomy.
Citation                                       Level &   Study Design & Sample        Intervention & Outcomes                   Results                                                        Comments
                                               Quality
Wallner PE, Endersbe LA, Marlin RL.            III-3 Ø   Non-randomised trial:        Minimum 2 servings per day                Lung: Significant reduction in the amount of weight            Mixed population with lung
Nutritional supplementation in two high-risk             matched historical control   (recommendation for 4 daily               loss in the intervention group compared with controls          cancer.
cancer populations. Current Therapeutic                  study, USA                   servings) of a nutritional supplement     (p=0.027 and p=0.039).
                                                                                      (each serving consisted of 1 rounded      H+N: Reduction in weight loss, however not
Research Clinical and Experimental
                                                         N=80 (40 intervention, 40    measuring spoon or 2 rounded              statistically significant.
1990;47:924-32.                                          control)                     tablespoons of powder added to 8               No meaningful correlation between weight loss and
                                                                                      ounces of fortified whole milk).               change in skin-fold thickness
                                                         2 high risk cancer           520 – 1040 calories per day, or 3640           Patient acceptance of supplements:
                                                         populations (lung n=20,      – 7280 calories per week (equal to a           - excellent: 5 patients
                                                         head and neck n=20)          potential gain of 1-2 pounds).                 - good: 19 patients
                                                         undergoing radiotherapy.     Encouraged to consume any amount               - fair: 12 patients
                                                         Minimum 4 weeks RT as        or variety of other liquids/solid food         - bad: 1 patient
                                                         primary definitive           they could tolerate.                           - indifferent: 1 patient
                                                         management or before or      Outcomes:                                      - no rating: 2 patients
                                                         after major surgery.         Efficacy: Weight changes, skin-fold            Side effects resulting in study discontinuance:
                                                                                      measurements, clinical parameters.             - Lung (n=10, with only 1 being judged as product
                                                                                      Safety and acceptance of supplement:      related) – 1 constipation, 4 bloating, 3 felt ill, 2 rash, 4
                                                                                      subjective responses.                     no reason, 1 dysphagia, 2 nausea, 3 emesis.
                                                                                      Time points:                                   - H+N (n=5, with only 1 being judged as product
                                                                                      Baseline, weekly during RT, 4 and 8       related) – 3 constipation, 4 admitted for implant, 1
                                                                                      week post.                                diarrhoea, 3 chemotherapy begun, 1 admitted to hospital.
Weed HG, Ferguson ML, Gaff RL, Hustead         IV +      Prospective, open-label,     Pre & post-operative protein and          Weight:                                                        No significant gain in weight
DS, Nelson JL, Voss AC. Lean body mass                   single-arm                   energy-dense nutritional supplement       - 70% (n= 27) maintained/gained from trial entry to            over time, however these pts
gain in patients with head and neck                      Columbus, USA                containing EPA from fish oil, in          time of hospital admission (mean wt gain 0.71 kg NS).          had all reported prior weight
                                                                                      addition to usual diet or tube feed - 2   - 57% (n= 30) maintained/gained through to the time of         loss and underwent major
squamous cell cancer treated perioperatively
                                                         N=31                         x 237ml/day before surgery and            hospital discharge (mean wt gain 0.66 kg NS).                  surgery, therefore absence of
with a protein- and energy-dense nutritional                                          during hospitalization (per 237ml:        Body composition (from trial entry to hospital discharge       weight loss is positive feature
supplement containing eicosapentaenoic                   Head and neck cancer         300 kilocalories, 16 g protein, 1.08g     n= 23).                                                        of the study. Lack of control
acid. Head & Neck 2010;21:21.                            SCC (Stage II-IV)            EPA).                                     LBM - increase 3.20 kg (p < .001)                              group diminishes the
                                                         & ≥5% weight loss x                                                    Fat mass - decrease 3.19 kg (p < .001)                         usefulness of this study.
                                                         6mth                         Outcomes:                                 Feasibility;
                                                         & major resection            ≥ 2wk pre op, pre-op admission,           Av. 1.8 containers/day before surgery and 1.5/day during       Feasible – appears to be
                                                         (curative intent).           discharge post-op (median 10d)            hospitalization.                                               tolerated by most patients.
                                                         BIA = BodyStat’s             Safety (clinical report of                2pts unwilling/unable to tolerate supplements but “easily
                                                         Quadscan.                    complications) and feasibility (pt        consumed and well tolerated by most subjects”.
                                                         Total body resistance 5,     report of intake).                        Safety:
                                                         50, 150, and 200 KHz.                                                  Post-op complications and apparent increased bleeding
                                                                                                                                discussed.
Wiggenraad RGJ, Flierman L, Goossens A,        IV Ø      Case series, the             Prophylactic pull PEG 1-2/52 pre-Rx.      Of those managing a normal diet pre treatment, tube            Very low wt loss during Rx
et al. Prophylactic gastrostomy placement                Netherlands                                                            feeding was commenced a median of 17 days from                 (2.8%) compared with other
and early tube feeding may limit loss of                                              PEG feeds (individual prescribed,         #1XRT (range -6 to 30), those with impaired swallow            similar case series: authors
                                                         N=55                         high energy multi-fibre) were             start after median of 2 days (range -31 to +30).               attribute to early
weight during chemoradiotherapy for
                                                                                      commenced when wt loss occurred or        Pre treatment wt loss was influenced by tumour site, T         commencement of feeding.
advanced head and neck cancer, a                         Unresectable stage III and   when oral intake was considered           stage (t4 vs. t1-3, p=0.02) and pre-Rx swallowing status
preliminary study. Clin Otolaryngol                      IV H&N Ca undergoing         insufficient after attempting oral        (p=0.03).
2007;32:384-90.                                          concurrent CRT with          nutrition, with supplements if            During Rx wt loss: mean=2.8% (SD 6.5%) & 2.3kg
                                                         curative intent.             necessary.                                (SD4.0kg). 10% of pts lost >10% during Rx, 18%
                                                                                                                                gained wt during Rx: all of whom had considerable wt
                                                         Reported consistency of      Weekly during Rx. Median follow-          loss before Rx.
                                                         food intake pre-Rx. 20%      up for pts still alive = 56 months        Weight loss during Rx independently assoc T stage (t4),
                                                         were on puree, 28% were      (range 15-79 months).                     pre treatment swallowing status, pre-Rx wt loss:
                                                         on liquids, pre treatment                                              probably because these pts commenced tube feeding
                                                         wt loss: 26% had                                                       earlier. Median tube use = 178 days (25 weeks).
                                                         lost>10kg, 52% 0-10kg.
Citation                                     Level &   Study Design & Sample      Intervention & Outcomes                 Results                                                      Comments
                                             Quality
Wilson PR, Herman J, Chubon SJ. Eating       IV Ø      Case series, qualitative   Descriptive study involving semi        Eating strategies: (Clusters: Food Choice and
strategies used by persons with head and               descriptive study, USA     structured interviews and a review of   Preparation – strategies 1, 4, 5, 7, 8, 9, 10, Acceptance
neck cancer during and after radiotherapy.                                        medical records.                        and Assistance – strategies 2, 3, Attitude Adoption –
                                                       N=11                                                               strategies 6, 11):
Cancer Nurs 1991;14:98-104.
                                                                                  Interviews within 6 months of RT
                                                       H&N cancer patients        completion identified treatment         1.    Ate only x (specific food/group) = 9
                                                       treated by RT.             problems and eating strategies, and     2.    Family/others prepared favourite foods = 7
                                                                                  responses were analysed.                3.    Family/others gave helpful advice (suggested
                                                                                                                                goods, nutrition book, medicine helped) = 6
                                                                                  Medical record review identified        4.    Nutritional supplements = 6
                                                                                  parameters of nutritional status.       5.    Changed food texture/consistency to soft or liquid
                                                                                  Nutritional status parameter values           =6
                                                                                  before, during and after radiotherapy   6.    Persisted in trying to eat (forced the food/ate
                                                                                  were retrospectively collected if             regardless) = 6
                                                                                  available.                              7.    Increased number of meals/ate continuously = 5
                                                                                                                          8.    Drank lots of liquids = 4
                                                                                  Outcomes:                               9.    Took pain medication before eating = 3
                                                                                  Eating strategies used by patients,     10. Left house while food cooked to avoid smell = 1
                                                                                  eating problems during radiotherapy,    11. Positive attitude = 1
                                                                                  changes after treatment, nutritional    Problems during radiotherapy:
                                                                                  status.                                 • Weight loss = 9, sore mouth/throat = 9, taste changes
                                                                                                                             = 8, no appetite = 8, hard to swallow = 7, dry
                                                                                                                             mouth/throat = 5, couldn’t eat what wanted = 5,
                                                                                                                             body hurt/tired = 4, hard to chew = 3, nauseated = 2,
                                                                                                                             pain = 2, couldn’t talk = 1, coughing spells = 1, thick
                                                                                                                             secretions = 1, smell changes = 1, constipation = 1.
                                                                                                                          • Subjects identified some treatment problems as
                                                                                                                             reasons for using a specific eating strategy.
                                                                                                                          Changes after treatment:
                                                                                                                          • 73% reported some aspects of eating improved since
                                                                                                                             completion of treatment (linked to decrease in
                                                                                                                             problems)
                                                                                                                          • 5 subjects – small weight gain
                                                                                                                          • 1 subject – improved appetite
                                                                                                                          • 8 subjects – many problems still existed and
                                                                                                                             continued strategies
                                                                                                                          • 2 subjects – problems worse after completion of
                                                                                                                                treatment
                                                                                                                          • 1 subject – started enteral feeding 5 months post
                                                                                                                                treatment
                                                                                                                          Nutritional Status:
                                                                                                                          • Reporting of nutritional parameters varied greatly
                                                                                                                          • Most consistently recorded nutrition measure was
                                                                                                                             weight: 7 subjects within normal range at start of
                                                                                                                             treatment, 3 subjects below normal weight range, 1
                                                                                                                             above normal range
                                                                                                                          • 4 subjects had weight loss pre treatment
                                                                                                                          • 9 subjects lost 6-36 pounds during treatment
                                                                                                                          • None returned to pre-treatment weight at time of
                                                                                                                             interview
                                                                                                                          • Average wt loss was 18lb (11% change from pre-
                                                                                                                              treatment wt)
Citation                                      Level &   Study Design & Sample      Intervention & Outcomes                   Results                                                     Comments
                                              Quality
Wilson WR, Hariri SM. Experience with         IV -      Case series, USA           Ponsky & Gaudere PEG insertion in         Minor complications = Wound infection requiring
percutaneous endoscopic gastrostomy on an                                          theatre under GA/heavy sedation,          topical 9 not uncommon)/IV Ab (n=1). GI bleed remote
otolaryngology service. Ear Nose Throat J               N=71                       used in conjunction with other H&N        from site (n=2), regurgitation & aspiration requiring PEJ
                                                                                   procedures.                               (n=2).
1995;74:760-2.
                                                        Pts requiring PEG
                                                        insertion (45 pts:         Outcomes:                                 Major: probable implantation of SCC to PEG site. Died
                                                        neurological impairment,   Complications, length of stay,            of intra-peritoneal & abdominal wall spread of tumour.
                                                        22 H&N ca, 2 misc).        survival.
Wood K. Audit of nutritional guidelines for   III-3 Ø   Historical cohort, UK      Implementation of Nutrition               With implementation of the guidelines:                      Difficult to ascertain whether
head and neck cancer patients undergoing                                           Guidelines to assist in identification                                                                the effects on outcomes are a
radiotherapy. J Hum Nutr Diet 2005;18:343-              N=32                       of patients for prophylactic PEG,          •    Weight maintenance during radiotherapy                result of the guidelines or the
                                                                                   including:                                      compared with 3% loss in previous years w/o           dietitian attendance at clinic.
51.
                                                        Head and neck cancer                                                       guidelines.
                                                        patients undergoing        •    Clinic A - Dietitian attendance at    •    Fewer patients lost ≥5% of their pre treatment
                                                        radiotherapy.                   head and neck clinic with full             body weight during radiotherapy (19 in 2003, 31
                                                                                        multidisciplinary team                     in 2001), no patients lost >10% (improvements
                                                                                        (including H+N surgeon, clinical           from previous years: 3 in 2001).
                                                                                        oncologist, speech pathologist,       •    Mean weight loss was less for those undergoing
                                                                                        dietitian, specialist nurse).              combined treatment than RT alone (-1.8% loss in
                                                                                   •    Clinic B - No dietitian                    2003 compared with -4.5% loss in 2001 for
                                                                                        attendance, only H+N surgeon               chemoradiotherapy).
                                                                                        and clinical oncologist.              •    All modes of treatment in 2003 had improved
                                                                                   Outcome data collected prospectively            weight changes compared with 2001.
                                                                                   after the implementation of                •    13 patients underwent enteral tube placement (5
                                                                                   nutritional guidelines in 2003 (n=32)           were already receiving tube feeds, 8 were placed
                                                                                   and compared with previous audits               prophylactically).
                                                                                   pre-implementation of guidelines in        •    No patients were admitted during RT (in 2001-
                                                                                   2001 (n=30).                                    50% of NGs admitted and 23% of PEGs admitted
                                                                                                                                   for feeding).
                                                                                   Time points: Week 1 of RT and then         •    93% had dietitian recommendations for long term
                                                                                   weekly, and f/up depending on clinic.           feeding followed, compared to 41% pre
                                                                                   Outcomes: Weight change,                        guidelines.
                                                                                   Admission rates, Prophylactic PEG          •    66% of patients were seen by dietitian pre RT (all
                                                                                   insertion, Dietetic recommendations             from Clinic A - dietitian present). None of the
                                                                                   followed, Referral practice.                    patients from Clinic B (no dietitian present) were
                                                                                                                                   seen prior to RT.

Yadav SPS, Gera A, Singh I, Chanda R.         IV -      Case series, India         Random selection of study patients,       Mean serum selenium levels at baseline:                     Control group selenium
Serum selenium levels in patients with head                                        n=30:                                      • Study group: 62.7 +/-1.97 v Control Gp: 101.4 +/-        levels only compared at
and neck cancer. J Otolaryngol                          N=23                       • Periodic random selection                    2.67 (p=<0.001).                                       baseline.
2002;31:216-9.                                                                         numbers from 150 patients with
                                                        Head and Neck Cancer           a diagnosis of head and neck          Effects of radiotherapy on selenium levels:                 Limited stats.
                                                        patients treated with          cancer.                                • Pre compared to post radiotherapy not statistically
                                                        radiotherapy.                                                              significant, p=>5                                     Limitations with study design
                                                                                   Control group, n=30:                       • 23 patients at 1 year:                                   and no correlation with the
                                                                                   Healthy age and sex matched                       - n=10 cured with increase in selenium levels       patient’s nutritional status.
                                                                                   volunteers                                            compared to controls.
                                                                                                                                     - n=13 residual disease at primary site or neck
                                                                                   Serum selenium levels:                                nodes with decrease in selenium levels
                                                                                   • Before radiotherapy                                 compared to controls.
                                                                                   • At completion of radiotherapy
                                                                                   • 1 year post radiotherapy
Citation                                      Level &   Study Design & Sample       Intervention & Outcomes                 Results                                                     Comments
                                              Quality
Zogbaum AT, Fitz P, Duffy VB. Tube            IV +      Retrospective case series   21 patients (17%) received tube         Groups similar at baseline wrt wt loss pre-XRT.             Exclusion d/t non-compliance
feeding may improve adherence to radiation                                          feeding (mainly PEGs managed by an      Significant. Decrease in BMI in non-tube fed group          to treatment protocol. Small
treatment schedule in head and neck cancer:             N=125                       RD) before or in the first week of      (24.3 +/- 5.6 to 22.8 +/- 5.5, p<0.005), BMI in tube fed    numbers. Indications for tube
                                                                                    XRT. 4 patients excluded d/t            group remained low but stable. Mean number of               feeding were not clear - e.g.
an outcomes study. Topics in Clinical
                                                        Head and neck cancer        secondary disease, non-compliance,      treatment days missed significant higher in non-tube fed    significant wt loss was not
Nutrition 2004;19:95-106.                               patients undergoing XRT     eating disorder, incomplete             group (p<0.01, 2.3 +/- 6.6 vs. 5.5 +/- 4.0). In the total   defined, physician beliefs and
                                                        +/- chemo +/- surgery.      documentation of disease stage.         sample wt loss was significant assoc with missed            pt desires not accounted for.
                                                                                    Indication = poor oral                  treatment days.
                                                                                    intake/significant wt loss. 17
                                                                                    matched controls who were provided
                                                                                    with oral supplements and diet plan
                                                                                    provided by a RD.

Zurlo F, Schutz Y, Pichard C, et al. What     III-3 Ø   Switzerland                 To determine energy requirements:       Early post op = DIT was 5.0 + 1%.
energy level is required to avoid nutrient                                          1) Early post-op period (first 5        Late post op = DIT was 8.5 + 2%.
depletion after surgery in oropharyngeal                N=8                              days)
                                                                                    = 1.3x BMR measured on day -1.          Fasting respiratory quotient (RQ) did not vary between
cancer? ORL J Otorhinolaryngol Relat Spec
                                                        Untreated male patients     2) Later post-op period (6th to 10th    the three BMR measurements.
1988;50:236-45.                                         affected by oral,                days)
                                                        pharyngeal or laryngeal     = 1.7x BMR measured on day 6.           During the feeding condition, RQ was significantly
                                                        epidermoid carcinoma                                                higher than during fasting (p< 0.05).
                                                        having elective surgery     Measurements taken on day -1, day 6
                                                        and at least 10 days of     and day 10.                             Energy balance was +2.4 + 2.6 kcal/kg/day on day 5 and
                                                        enteral nutrition by        • RMR measurements took place           +17.6 + 3.1 kcal/kg/day on day 9 (p<0.001).
                                                        nasogastric tube.                during continuous feeding
                                                                                    • BMR measurements were                 Albumin decreased at day 6
                                                                                         carried out between 7-9am (after   Prealbumin decreased at day 6
                                                                                         fasting overnight)                 (p< 0.005)

                                                                                    Outcomes:
                                                                                    • Diet Induced Thermogenesis
                                                                                        (DIT)
                                                                                    • Nitrogen Intake and Excretion
                                                                                    • Body Composition
                                                                                    • Biochemical Variables in Blood
                                                                                        and Urine

				
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