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Report for Mutation V18M
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
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.
NCT02522988 Fatigue Behavioral: Open-label placebo intervention MeSH:Fatigue
HPO:Fatigue
If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses. --- Val18Met ---
Primary Outcomes
Description: Unit of measure: number of enrollees / number of eligible participants as a measure of feasibility.
Measure: Enrollment Rate Time: End of Study (7 weeks)Description: Unit of measure: number of accrued participants / recruitment goal (80); odds ration of expected time-to-first participant/ actual time-to-first patient enrollment.
Measure: Accrual Rate as a Measure of Feasibility Time: End of Study (7 weeks)Description: Unit of measure: number of placebos taken / number prescribed (84)
Measure: Adherence Rate as a Measure of Feasibility Time: End of Study (7 weeks)Description: Unit of measure: number eligible for enrollment / number screened
Measure: Eligibility as a measure of Feasibility Time: End of Study (7 weeks)Description: Unit of measure: number retained in study / number enrolled (goal = 75% of enrolled
Measure: Retention as a measure of Acceptability Time: End of Study (7 weeks)Secondary Outcomes
Description: 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)
Measure: Measure of fatigue manifestation Time: Baseline, 3 weeks, 4 weeks and 7 weeksDescription: 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)
Measure: Measurement of impact of fatigue on quality of life Time: Baseline, 3 weeks, 4 weeks and 7 weeksDescription: Unit of measure: units on a scale using the FACT-Fatigue instrument; scale for impact is 0 = not at all; 10 = very much.
Measure: Measurement of the impact of fatigue on physical function Time: Baseline, 3 weeks, 4 weeks and 7 weeksDescription: 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)
Measure: Measurement of fatigue severity Time: Baseline, 3 weeks, 4 weeks and 7 weeksOther Outcomes
Description: 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.
Measure: Test for the presence of a COMT Val158Met/Val or Val/Val variant gene Time: Baseline