The purpose of this randomized-controlled, crossover pilot trial is to evaluate the
feasibility, acceptability and effects of a non-deceptive (open-label) administration of
placebo pills for treating cancer related fatigue (CRF). If significant effects are found,
the investigators will later determine if the presence of a COMT Val18Met genotype variant
predicts placebo responses.
The investigators will conduct a pilot randomized-controlled, crossover trial to evaluate the
feasibility, acceptability and effect of the open-label administration of placebo pills on
CRF and associated psychosocial factors (e.g., emotional health, social health, quality of
life, etc.) for cancer survivors (CSs) who have completed all cancer treatments yet continue
to experience CRF. Additionally, in an exploratory manner, the investigators will collect DNA
saliva specimens that will be analyzed for potential biomarkers that may predict placebo
responses. To do this, investigators will use a 7-week, single site, two-parallel arm,
randomized controlled crossover pilot study to determine the feasibility, acceptability and
effects of an Open Label Placebo Intervention (OLPI) on CSs who completed cancer treatments
at least 6 months prior to enrollment in the study and report a fatigue score of 4 or greater
on a 0-10 scale. Investigators will enroll 80 eligible CS participants who will be randomized
into two groups of 40 (Group1 and Group2 ). In this crossover study, participants in Group1,
will receive an OLP (placebo pill) for 21-days (Period 1)and Group2 (Observational Controls)
will not. After a 1-week washout period, Group2 will receive the OLP for 21-days (Period 2)
and Group1 (Observational Controls) will not.
- Clinical diagnosis of Stage II - IV cancer;
- Completed primary treatment 6months to 10 years;
- Report ≥4 (moderate fatigue) on a 0-10 fatigue severity rating scale;
- Agree not to change any medications or treatments during the study;
- Willingness to make 4 clinical site visits over the course of the 49-day study.
- Stage 1 cancer;
- Uncontrolled diabetes;
- Uncontrolled COPD;
- Uncontrolled ischemic heart disease;
- Uncontrolled liver/kidney diseases;
- Uncontrolled autoimmune diseases;
- Uncontrolled psychiatric or cognitive diseases.