Claim List for Fatigue Therapy
Claim Clinical trial issues Comments
Stimulin™ is indicated for the The drug is not
treatment of the symptoms of addressing the root
fatigue associated with cancer cause of fatigue – just
influencing the
reported symptoms.
Influenced by
concomitant treatments
Stimulin™ is indicated for the Can be assessed after Subgroups?
treatment of the symptoms of treatment but etiology is a Treatment of fatigue
fatigue associated with cancer therapy question. symptoms vs treatment
(chemotherapy or radiotherapy) of fatigue
Stimulin is indicated for the Clinical trials require This claim would
prevention of fatigue symptoms baseline data before require near total
associated with cancer therapy cancer therapy. absence of fatigue in
(chemotherapy or radiotherapy) subjects at study end.
Would need to know the
relative incidence of
treatable fatigue after a
given cancer therapy to
determine sample size.
Stimulin is indicated for the treatment This implies a treatment More difficult claim
of the fatigue associated with cancer. of the entire fatigue because the source of
spectrum. the fatigue is obscured
by treatment
Higher hurdle for clinical
trials.
Comments for all claims:
These claims do not address fatigue associated with anemia. All participants will
have normal Hct.
Consider the sources of fatigue as confounders
o Depression / mood disorder
o Cancer treatment
o Surgery
Are the symptoms of fatigue unidimensional? If so will there be subclaims for
individual components?
o Claim for improvement in function
o Claim for subjective improvement in cognitive aspects of fatigue
A challenge will be how to limit claim to cancer or cancer treatment associated fatigue
and not have a “claim creep” to include chronic fatigue syndrome, liver disease etc.
Fatigue Claims and Endpoints
Claims Clinical Trial Endpoint Discussion:
Advertisement Product Label Concept Measures Criteria
„I‟m on chemotherapy Indication: XXX is Fatigue: Alertness Improvement of Study Design Issues:
for my cancer. Some indicated for treatment cognitive NRS 10% of the possible
days, I am so tired I of chemotherapy- Fatigue: physical Tiredness range of the scale RCT required
cannot get out of bed. I related fatigue in Fatigue: NRS (i.e., >1 points on Diagnosis of fatigue at
can‟t think clearly, and patients with XXX emotional Motivation 11 point scale) baseline requires
I have no energy to do cancers NRS severity 2 on all 3
the things I love to do fatigue endpoints to
like working in my Clinical studies: enable range to
garden or play cards In three randomized, improve by 2 points for
with my grandson. I double-blind, placebo meaningfulness criteria
asked my doctor if controlled clinical Assumes we can
there way anything that trials in breast, demonstrate that a
could help me get over prostate, NSCLC, and change of 2 points on
this awful tiredness. CR cancer patients the NRS is meaningful
She told me that I was receiving various and reliably detectable
experiencing chemotherapy on NRS for all three
chemotherapy-induced regimens post surgery, endpoints
fatigue, and that there XXX plus standard of Timing of fatigue
was a new medication I care was compared to assessment needs to
could try that might standard of care alone. show improvement
help. Patient-rated alertness, while patients are still
tiredness, and energy on chemotx to claim
After 5 weeks on XXX NRS were coprimary chemotx related
I can get up in the endpoints for all 3 fatigue.
morning and not feel trials found 3x more Issues:
tired. I‟m enjoying likely to have a 10% 1. how to select
time with my grandkids improvement in the
Claims Clinical Trial Endpoint Discussion:
Advertisement Product Label Concept Measures Criteria
(cut to picture of cognitive, physical patients to ensure
playing cards with and emotional chemotx is the
young boy) and even measures of cause of fatigue.
back working in the chemotherapy-related 2. how many different
garden (in garden with fatigue for patients types of cancers,
hat and gloves, who received prior treatment
kneeling as put weeds treatments containing histories etc would
in bucket. XXX plus standard of be required for a
care general chemotx
fatigue claim
3.