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

Dana-Farber Cancer Institute

Status

Terminated

Conditions

Fatigue in Cancer Survivors

Treatments

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02452710

14-583

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 ≥10.
Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period. (per provider report)