This research study is being conducted to investigate the safety and effectiveness of the drug Fisetin for mild or moderate carpal tunnel syndrome (CTS).
FITCATS trial will enroll approximately 40 subjects with mild-moderate CTS and evidence of senescence from blood markers into a short term (180 days) prospective phase 2 study of Fisetin therapy, using as outcome measures a well-accepted patient reported outcome questionnaire (Boston CTS questionnaire, BCTQ) as well as reduction from baseline in senescence markers in the blood, including SASP factors and inflammatory markers. Based on the known performance of the BCTQ, the investigators estimate that a sample size of 40 will be sufficient to show a clinically important difference in outcome, if it is present. Each subject will be enrolled for a six-month period. Subjects may withdraw at any time, for any reason.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in Boston Carpal Tunnel Syndrome (BCTQ) Score
The Boston Carpal Tunnel Syndrome questionnaire (BCTQ) assesses symptom severity and overall function of subjects with Carpel Tunnel Syndrome. The questionnaire consists of two sections: 1. Symptom Severity (11 questions) and 2. Functional Status (8 questions). Subjects are asked to rate each question on a scale of 1 to 5. The mean score for each section is calculated by summing the individual question responses and diving by the number of questions resulting in a total score ranging from 1 to 5, with higher scores indicating greater symptom severity and dysfunction.
Time frame: Baseline, 60 days
Percent Decrease in Blood Markers of Cellular Senescence, e.g., p16, IL-6, IL-15, TNF, PAI-1, ICAM-1, and Additional Exploratory, Novel Assays
Blood samples collected to measure percent decrease in circulating blood biomarkers of senescence
Time frame: Baseline, 60 days
Percent Decrease in Blood Markers of Cellular Senescence in Long-term
percent decrease in blood markers of cellular senescence, e.g., p16, IL-6, IL-15, TNF, PAI-1, ICAM-1, and additional exploratory, novel assays
Time frame: Baseline, 180 days
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