Clinical trial NCT02522988: The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
Official title: The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: cancer-related fatigue
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment Rate
timeFrame: End of Study (7 weeks)
measure: Accrual Rate as a Measure of Feasibility
timeFrame: End of Study (7 weeks)
measure: Adherence Rate as a Measure of Feasibility
timeFrame: End of Study (7 weeks)
measure: Eligibility as a measure of Feasibility
timeFrame: End of Study (7 weeks)
measure: Retention as a measure of Acceptability
timeFrame: End of Study (7 weeks)
Secondary outcomes:
measure: Measure of fatigue manifestation
timeFrame: Baseline, 3 weeks, 4 weeks and 7 weeks
measure: Measurement of impact of fatigue on quality of life
timeFrame: Baseline, 3 weeks, 4 weeks and 7 weeks
measure: Measurement of the impact of fatigue on physical function
timeFrame: Baseline, 3 weeks, 4 weeks and 7 weeks
measure: Measurement of fatigue severity
timeFrame: Baseline, 3 weeks, 4 weeks and 7 weeks
Other outcomes:
measure: Test for the presence of a COMT Val158Met/Val or Val/Val variant gene
timeFrame: Baseline
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.