Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors

Not Applicable

Terminated

• Conditions: Fatigue in Cancer Survivors
• Interventions: Other: Placebo

• Registration Number: NCT02452710
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study is evaluating the usefulness of a placebo (a tablet with no active ingredients) on fatigue in cancer survivors.

Detailed Description

Fatigue can be a problem for some people after cancer treatment. In clinical trials, placebos (tablets with no active ingredients) have been shown to improve symptoms of some medical conditions including fatigue. This study is being done to test the usefulness of taking placebos for improving cancer-related fatigue. In this study, the investigators are testing whether symptoms of fatigue will improve when people know they are taking a tablet with no active ingredients.

This is a randomized study, which means the participant will be put into one of two groups. Because no one knows which of the study options is best, the participant will be 'randomized' into one of the two study groups. Randomization means that the participant will be put into a group by chance. It is like flipping a coin. Neither the participant nor the research doctor will choose what group he or she will be in. The participant will have an equal chance of being placed in each of the groups.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-25
• Study Start: 2015-08
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Cancer survivor, with no evidence of active disease
• ≥18 years of age
• ≥6 months and <10 years post active treatment
• Reports being bothered by fatigue in the past month and has a score of <43 on FACIT-F.
• Able to read and write in English

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Exclusion Criteria

• Being evaluated or likely to be evaluated for a medical cause of fatigue (e.g., anemia, hypothyroidism) during the study. (per provider report)
• Have indications of sleep apnea as assessed by Epworth Sleepiness scale score ≥10.
• Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period. (per provider report)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open-Label Placebo	Placebo	- Placebo Tablets-Twice a day for 3-4 weeks

Primary Outcome Measures

Name	Time	Method
Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale	Change from baseline to Day 8, and from baseline to Day 22	13-item self-report measure of fatigue

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale	Change from baseline to Day 22	12-item HRQOL measure
Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)	Change from baseline to Day 22	35-items self-report mood scale
Subjective Sense of Change on fatigue, readiness for exercise and quality of life	Change from baseline to Day 8, and change from Baseline to Day 22	3-item measure that asks participants to report changes to their level of fatigue, ability to engage in physical activity, and overall quality of life since the beginning of the research program.

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States