Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS)

Overview

About this study

The purpose of this trial is to determine if Fisetin has any effect on CTS, powered based on the results of known effective treatments of CTS. The primary hypothesis is that the Boston CTS questionnaire score will improve by 1 point from pre-treatment to 60 days post-treatment. The secondary hypothesis is that clinical improvement will be proportional to the effect in reducing blood markers of cellular senescence

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult men and post-menopausal women between age 45 and 80.
  • 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.
  • Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram.
  • A clinical diagnosis of carpal tunnel syndrome.
  • Able to complete English-language questionnaires and clinical evaluations.

Exclusion Criteria:

  • Unable or unwilling to give informed consent.
  • Previous carpal tunnel release on the study hand.
  • History of steroid injection into carpal tunnel or surgery on the affected wrist within the past 6 months.
  • Currently take a steroid medication either regularly or on as needed basis.
  • Currently taking warfarin (medication can be safely held during the following times:
    • Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1);
    • Immediately before the 3rd IP administration (Day 29) until at least 10 hours after the 4th IP administration (Day 30).
  • Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases).
  • 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.
  • Any of the following clinical diagnoses or conditions:
    • Cervical radiculopathy; 
    • Renal failure (see below);
    • Liver disease (see below);
    • Taking warfarin;
    • Peripheral nerve disease;
    • Uncontrolled diabetes (see below); or
    • Other metabolic disorder (as per clinical judgement).
  • The following laboratory tests as indicated or as per clinical judgement:
    • fasting plasma glucose > 200 as a marker of poor diabetic control;
    • CBC w/diff with Hgb < 12 as a marker of poor nutrition, creatinine > 2.5 as a marker of advanced kidney disease;
    • AST > 100 as a marker of liver disease;
    • Bilirubin > 2.0 as a marker of liver disease;
    • Cystatin c > 3 as a marker of advanced kidney disease;
    • A1c > 8 as a marker of poor diabetic control;
    • CRP > 10 as a marker of systemic inflammation;
    • ESR > 25 as a marker of systemic inflammation.
  • Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
  • Women of child-bearing potential.

Eligibility last updated 2/25/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Peter Amadio, M.D.

Open for enrollment

Contact information:

Paul Cox

(507) 538-3561

Cox.Paul@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20532377

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