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

Not Applicable

Completed

• Conditions: Fatigue
• Interventions: Behavioral: Open-label placebo intervention

• Registration Number: NCT02522988
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-14
• Primary Completion: 2016-05-01
• Study Completion: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1a	Open-label placebo intervention	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.
Group 2b	Open-label placebo intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measure of fatigue manifestation	Baseline, 3 weeks, 4 weeks and 7 weeks	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)
Measurement of impact of fatigue on quality of life	Baseline, 3 weeks, 4 weeks and 7 weeks	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)
Measurement of fatigue severity	Baseline, 3 weeks, 4 weeks and 7 weeks	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)
Measurement of the impact of fatigue on physical function	Baseline, 3 weeks, 4 weeks and 7 weeks	Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much.

Trial Locations

Locations (1)

UAB Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States