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The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

NCT02522988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2021-09-24

No results posted yet for this study

Summary

The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.

Conditions

Interventions

BEHAVIORAL

Open-label placebo intervention

An open-label placebo intervention is an administered placebo that is fully disclosed to participants. It is delivered with a script that tells participants they are receiving placebos; placebos have been found to have effects that are comparable to some clinical treatments; placebos work because of conditioning, expectancies, interactions with care team and biochemical factors (i.e., dopamine, endorphins). Participants are given placebos to take for a 3-week period and will not receive placebos for a 4-week period (including a one-week washout period).

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-05-01
Completion
2021-08-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522988 on ClinicalTrials.gov