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

Fatigue in Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02452710
• Other study ID #: 14-583
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: December 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Fatigue in Cancer Survivors

Intervention

Other:
• Placebo
Open-label placebo

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale	13-item self-report measure of fatigue	Change from baseline to Day 8, and from baseline to Day 22
Secondary	Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)	35-items self-report mood scale	Change from baseline to Day 22
Secondary	Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale	12-item HRQOL measure	Change from baseline to Day 22
Secondary	Subjective Sense of Change on fatigue, readiness for exercise and quality of life	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.	Change from baseline to Day 8, and change from Baseline to Day 22