Fatigue Clinical Trial
— OLPIOfficial title:
The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
NCT number | NCT02522988 |
Other study ID # | X150506002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | August 1, 2021 |
Verified date | September 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | UAB Comprehensive Cancer Center | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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
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 |
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