NCT02522988

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

August 5, 2015

Last Update Submit

September 22, 2021

Conditions

Fatigue

Keywords

cancer-related fatigue

Outcome Measures

Primary Outcomes (5)

  • Enrollment Rate

    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

    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

    Unit of measure: number of placebos taken / number prescribed (84)

    End of Study (7 weeks)

  • Eligibility as a measure of Feasibility

    Unit of measure: number eligible for enrollment / number screened

    End of Study (7 weeks)

  • Retention as a measure of Acceptability

    Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled

    End of Study (7 weeks)

Secondary Outcomes (4)

  • Measure of fatigue manifestation

    Baseline, 3 weeks, 4 weeks and 7 weeks

  • Measurement of impact of fatigue on quality of life

    Baseline, 3 weeks, 4 weeks and 7 weeks

  • Measurement of the impact of fatigue on physical function

    Baseline, 3 weeks, 4 weeks and 7 weeks

  • Measurement of fatigue severity

    Baseline, 3 weeks, 4 weeks and 7 weeks

Other Outcomes (1)

  • Test for the presence of a COMT Val158Met/Val or Val/Val variant gene

    Baseline

Study Arms (4)

Group 1a

EXPERIMENTAL

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

Group 2a

NO INTERVENTION

During the first 3-week period of the study, Group 2 will serve as the comparator arm.

Group 1b

NO INTERVENTION

During the last 3-week period of the study, Group 1 will serve as the comparator arm.

Group 2b

EXPERIMENTAL

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

Interventions

Open-label placebo interventionBEHAVIORAL

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).

Also known as: OLPI
Group 1aGroup 2b

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Related Publications (4)

  • Kelley JM, Kaptchuk TJ, Cusin C, Lipkin S, Fava M. Open-label placebo for major depressive disorder: a pilot randomized controlled trial. Psychother Psychosom. 2012;81(5):312-4. doi: 10.1159/000337053. Epub 2012 Aug 1. No abstract available.

    PMID: 22854752BACKGROUND

  • Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.

    PMID: 24401940BACKGROUND

  • Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.

    PMID: 21203519RESULT

  • Hoenemeyer TW, Baidwan NK, Hall K, Kaptchuk TJ, Fontaine KR, Mehta TS. An Exploratory Analysis of the Association Between Catechol-O-Methyltransferase and Response to a Randomized Open-Label Placebo Treatment for Cancer-Related Fatigue. Front Psychiatry. 2021 Jun 29;12:684556. doi: 10.3389/fpsyt.2021.684556. eCollection 2021.

    PMID: 34267689DERIVED

Related Links

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Education and Support Services, Comprehensive Cancer Center

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 14, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

August 1, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Locations

US(1)