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

Fatigue Clinical Trial

— OLPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522988
• Other study ID #: X150506002
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 1, 2021
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue

Intervention

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).

Locations

Country	Name	City	State
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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: 10.1 — View 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. Epub 2012 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Test for the presence of a COMT Val158Met/Val or Val/Val variant gene	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
Primary	Enrollment Rate	Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.	End of Study (7 weeks)
Primary	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)
Primary	Adherence Rate as a Measure of Feasibility	Unit of measure: number of placebos taken / number prescribed (84)	End of Study (7 weeks)
Primary	Eligibility as a measure of Feasibility	Unit of measure: number eligible for enrollment / number screened	End of Study (7 weeks)
Primary	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	Measure of fatigue manifestation	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
Secondary	Measurement of impact of fatigue on quality of life	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
Secondary	Measurement of the impact of fatigue on physical function	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
Secondary	Measurement of fatigue severity	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

External Links

•   Open Label Placebo Effects