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

The University of Alabama at Birmingham

Status: Completed

Conditions: Fatigue

Treatments: Behavioral: Open-label placebo intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02522988

X150506002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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74 participants in 4 patient groups

Group 1a

Experimental group

Description:

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.

Treatment:

Behavioral: Open-label placebo intervention

Group 2a

No Intervention group

Description:

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

Group 1b

No Intervention group

Description:

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

Group 2b

Experimental group

Description:

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.

Treatment:

Behavioral: Open-label placebo intervention