A Study of Fisetin to Treat Carpal Tunnel Syndrome
Study Details
Study Description
Brief Summary
This research study is being conducted to investigate the safety and effectiveness of the drug Fisetin for mild or moderate carpal tunnel syndrome (CTS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Carpal Tunnel Syndrome Adult men and post-menopausal women who have a clinical diagnosis for Carpal Tunnel Syndrome (CTS) will receive Fisetin for 2 day periods for 2 months |
Drug: Fisetin
100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
|
Outcome Measures
Primary Outcome Measures
- Change in CTS symptoms [Baseline, 60 days]
Measured using the self-reported Boston Carpal Tunnel Syndrome questionnaire (BCTQ) score to assess symptoms severity and overall function of subjects with CTS. Questionnaire consist of 11 questions for symptoms severity and 8 questions for function on a 1-5 point scale for each question; higher scores indicate greater severity and dysfunction.
Secondary Outcome Measures
- 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 [Baseline, 60 days]
Blood samples collected to measure percent decrease in circulating blood biomarkers of senescence
- percent decrease in blood markers of cellular senescence in long-term [Baseline, 180 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult men and post-menopausal women between age 45 and 80.
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Symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long, or radial border of ring finger.
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Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram.
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A clinical diagnosis of carpal tunnel syndrome.
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Able to complete English-language questionnaires and clinical evaluations.
Exclusion Criteria:
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Unable or unwilling to give informed consent.
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Previous carpal tunnel release on the study hand.
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History of steroid injection into carpal tunnel or surgery on the affected wrist within the past 6 months.
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Currently take a steroid medication either regularly or on as needed basis.
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Currently taking warfarin (medication can be safely held during the following times):
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Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1);
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Immediately before the 3rd IP administration (Day 29) until at least 10 hours after the 4th IP administration (Day 30).
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Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases).
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Drugs listed as part of the exclusion criteria are not permitted during each of the two 2-day courses of treatment with Fisetin. If patients are required to initiate these medications within the 2-day period then they will be removed from the study primarily due to risk of drug-drug interaction.
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Any of the following clinical diagnoses or conditions:
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Cervical radiculopathy;
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Renal failure (see below);
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Liver disease (see below);
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Taking warfarin;
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Peripheral nerve disease;
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Uncontrolled diabetes (see below); or
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Other metabolic disorder (as per clinical judgement).
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The following laboratory tests as indicated or as per clinical judgement:
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Fasting plasma glucose > 200 as a marker of poor diabetic control;
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CBC w/diff with Hgb < 12 as a marker of poor nutrition, creatinine > 2.5 as a marker of advanced kidney disease;
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AST > 100 as a marker of liver disease;
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Bilirubin > 2.0 as a marker of liver disease;
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Cystatin c > 3 as a marker of advanced kidney disease;
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A1c > 8 as a marker of poor diabetic control;
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CRP > 10 as a marker of systemic inflammation;
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ESR > 25 as a marker of systemic inflammation.
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Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
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Women of child-bearing potential.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Peter C. Amadio, M.D.
Investigators
- Principal Investigator: Peter C Amadio, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-010406