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

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

Study Overview

• Status: Terminated
• Conditions: Fatigue in Cancer Survivors
• Intervention / Treatment: Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-Label Placebo; - Placebo Tablets-Twice a day for 3-4 weeks	Other: Placebo; Open-label placebo
No Intervention: NT-Control; - No Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Christopher Recklitis, PhD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Fatigue in Cancer Survivors
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 14-583