The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

Conditions
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Fatigue

Intervention / Treatment
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* Behavioral: Open-label placebo intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Stage 1 cancer; Uncontrolled diabetes; Uncontrolled COPD; Uncontrolled ischemic heart disease; Uncontrolled liver/kidney diseases; Uncontrolled autoimmune diseases; Uncontrolled psychiatric or cognitive diseases.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1a<br>During the first 3-week period of the study, Group 1 will serve as the experimental arm and will receive the open-label placebo intervention. Group 1 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days. | Behavioral: Open-label placebo intervention<br>* An open-label placebo intervention is an administered placebo that is fully disclosed to participants. It is delivered with a script that tells participants they are receiving placebos; placebos have been found to have effects that are comparable to some clinical treatments; placebos work because of conditioning, expectancies, interactions with care team and biochemical factors (i.e., dopamine, endorphins). Participants are given placebos to take for a 3-week period and will not receive placebos for a 4-week period (including a one-week washout period).<br>* Other names: OLPI;|
| No Intervention: Group 2a<br>During the first 3-week period of the study, Group 2 will serve as the comparator arm. | |
| No Intervention: Group 1b<br>During the last 3-week period of the study, Group 1 will serve as the comparator arm. | |
| Experimental: Group 2b<br>During the last 3-week period of the study, Group 2 will serve as the experimental arm and will receive the open-label placebo intervention.Group 2 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days. | Behavioral: Open-label placebo intervention<br>* An open-label placebo intervention is an administered placebo that is fully disclosed to participants. It is delivered with a script that tells participants they are receiving placebos; placebos have been found to have effects that are comparable to some clinical treatments; placebos work because of conditioning, expectancies, interactions with care team and biochemical factors (i.e., dopamine, endorphins). Participants are given placebos to take for a 3-week period and will not receive placebos for a 4-week period (including a one-week washout period).<br>* Other names: OLPI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility. | End of Study (7 weeks) | 
| Accrual Rate as a Measure of Feasibility | Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment. | End of Study (7 weeks) | 
| Adherence Rate as a Measure of Feasibility | Unit of measure: number of placebos taken / number prescribed (84) | End of Study (7 weeks) | 
| Eligibility as a measure of Feasibility | Unit of measure: number eligible for enrollment / number screened | End of Study (7 weeks) | 
| Retention as a measure of Acceptability | Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled | End of Study (7 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of fatigue manifestation | Units of measure: units on a scale using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument. 30-questions measure the global, somatic, affective, behavioral and cognitive manifestations of fatigue. Scale for items = 0 (not at all) - 4 (extremely) | Baseline, 3 weeks, 4 weeks and 7 weeks | 
| Measurement of impact of fatigue on quality of life | Unit of measure: units on a scale using the Medical Outcomes Study 36-Item Short Form (MOS-36) instrument. The 36-item instrument measures the impact of fatigue on vitality, physical functioning, emotional functioning, social functioning and mental health. Scale for items = 1 (limited a lot) - 3 (Not limited at all) | Baseline, 3 weeks, 4 weeks and 7 weeks | 
| Measurement of the impact of fatigue on physical function | Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much. | Baseline, 3 weeks, 4 weeks and 7 weeks | 
| Measurement of fatigue severity | Units of measure: units on a scale using the Fatigue Symptom Inventory (FSI) instrument. Scale = 0 (no fatigue / no interference) to 10 (extreme fatigue / interference) | Baseline, 3 weeks, 4 weeks and 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer-related fatigue