Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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 ≥
- •Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period. (per provider report)
Arms & Interventions
Open-Label Placebo
- Placebo Tablets-Twice a day for 3-4 weeks
Intervention: Placebo (Other)
NT-Control
- No Placebo Tablets
Outcomes
Primary Outcomes
Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale
Time Frame: Change from baseline to Day 8, and from baseline to Day 22
13-item self-report measure of fatigue
Secondary Outcomes
- Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale(Change from baseline to Day 22)
- Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)(Change from baseline to Day 22)
- 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)
Investigators
Christopher Recklitis, Ph.D
Principal Investigator
Dana-Farber Cancer Institute