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

September 22, 2021 updated by: Theresa W. Hoenemeyer, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a pilot randomized-controlled, crossover trial to evaluate the feasibility, acceptability and effect of the open-label administration of placebo pills on CRF and associated psychosocial factors (e.g., emotional health, social health, quality of life, etc.) for cancer survivors (CSs) who have completed all cancer treatments yet continue to experience CRF. Additionally, in an exploratory manner, the investigators will collect DNA saliva specimens that will be analyzed for potential biomarkers that may predict placebo responses. To do this, investigators will use a 7-week, single site, two-parallel arm, randomized controlled crossover pilot study to determine the feasibility, acceptability and effects of an Open Label Placebo Intervention (OLPI) on CSs who completed cancer treatments at least 6 months prior to enrollment in the study and report a fatigue score of 4 or greater on a 0-10 scale. Investigators will enroll 80 eligible CS participants who will be randomized into two groups of 40 (Group1 and Group2 ). In this crossover study, participants in Group1, will receive an OLP (placebo pill) for 21-days (Period 1)and Group2 (Observational Controls) will not. After a 1-week washout period, Group2 will receive the OLP for 21-days (Period 2) and Group1 (Observational Controls) will not.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Uab Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Stage II - IV cancer;
  • Completed primary treatment 6months to 10 years;
  • Report ≥4 (moderate fatigue) on a 0-10 fatigue severity rating scale;
  • Agree not to change any medications or treatments during the study;
  • Willingness to make 4 clinical site visits over the course of the 49-day study.

Exclusion Criteria:

  • Stage 1 cancer;
  • Uncontrolled diabetes;
  • Uncontrolled COPD;
  • Uncontrolled ischemic heart disease;
  • Uncontrolled liver/kidney diseases;
  • Uncontrolled autoimmune diseases;
  • Uncontrolled psychiatric or cognitive diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1a
During the first 3-week period of the study, Group 1 will serve as the experimental arm and will receive the open-label placebo intervention. Group 1 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days.
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).
Other Names:
  • OLPI
NO_INTERVENTION: Group 2a
During the first 3-week period of the study, Group 2 will serve as the comparator arm.
NO_INTERVENTION: Group 1b
During the last 3-week period of the study, Group 1 will serve as the comparator arm.
EXPERIMENTAL: Group 2b
During the last 3-week period of the study, Group 2 will serve as the experimental arm and will receive the open-label placebo intervention.Group 2 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days.
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).
Other Names:
  • OLPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Rate
Time Frame: End of Study (7 weeks)
Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.
End of Study (7 weeks)
Accrual Rate as a Measure of Feasibility
Time Frame: End of Study (7 weeks)
Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.
End of Study (7 weeks)
Adherence Rate as a Measure of Feasibility
Time Frame: End of Study (7 weeks)
Unit of measure: number of placebos taken / number prescribed (84)
End of Study (7 weeks)
Eligibility as a measure of Feasibility
Time Frame: End of Study (7 weeks)
Unit of measure: number eligible for enrollment / number screened
End of Study (7 weeks)
Retention as a measure of Acceptability
Time Frame: End of Study (7 weeks)
Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled
End of Study (7 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of fatigue manifestation
Time Frame: Baseline, 3 weeks, 4 weeks and 7 weeks
Units of measure: units on a scale using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument. 30-questions measure the global, somatic, affective, behavioral and cognitive manifestations of fatigue. Scale for items = 0 (not at all) - 4 (extremely)
Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of impact of fatigue on quality of life
Time Frame: Baseline, 3 weeks, 4 weeks and 7 weeks
Unit of measure: units on a scale using the Medical Outcomes Study 36-Item Short Form (MOS-36) instrument. The 36-item instrument measures the impact of fatigue on vitality, physical functioning, emotional functioning, social functioning and mental health. Scale for items = 1 (limited a lot) - 3 (Not limited at all)
Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of the impact of fatigue on physical function
Time Frame: Baseline, 3 weeks, 4 weeks and 7 weeks
Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much.
Baseline, 3 weeks, 4 weeks and 7 weeks
Measurement of fatigue severity
Time Frame: Baseline, 3 weeks, 4 weeks and 7 weeks
Units of measure: units on a scale using the Fatigue Symptom Inventory (FSI) instrument. Scale = 0 (no fatigue / no interference) to 10 (extreme fatigue / interference)
Baseline, 3 weeks, 4 weeks and 7 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test for the presence of a COMT Val158Met/Val or Val/Val variant gene
Time Frame: Baseline
Investigators will collect and store saliva samples so, should significant OLPI effects be obtained, we can evaluate whether a potential biomarker (COMT Val158Met variant) associates with placebo responsiveness.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (ESTIMATE)

August 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X150506002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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