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Flavonoid

Fisetin for Carpal Tunnel Syndrome

Phase 2
Recruiting
Led By Peter C Amadio
Research Sponsored by Peter C. Amadio, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females between age 21 and 80 years of age
A clinical diagnosis of carpal tunnel syndrome. Patients with bilateral CTS will have the more severe hand enrolled
Must not have
Creatinine >2.5, cystatin c >3 or eGFR< 25 ml/min/1.73 m2 as a marker of advanced kidney disease
Hemoglobin < 7g/dL; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤40,000/μL (≤40 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count <0.3 x 109/L at screening as a marker of poor nutrition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 180 days
Awards & highlights

Summary

This trial is testing Fisetin, a supplement, to see if it can help people with mild to moderate carpal tunnel syndrome. The study will involve 40 participants who show signs of aging cells in their blood. Fisetin aims to reduce these aging cells and inflammation, potentially improving CTS symptoms.

Who is the study for?
Adults aged 21-80 with mild or moderate carpal tunnel syndrome can join this study. Women must not be pregnant, breastfeeding, or planning to become pregnant and should use birth control. Participants shouldn't have certain health conditions like severe liver disease, uncontrolled diabetes, recent wrist treatments, or be taking specific medications.
What is being tested?
The trial is testing the safety and effectiveness of Fisetin for treating carpal tunnel syndrome. It aims to see if Fisetin can relieve numbness or tingling in fingers due to CTS by comparing symptoms before and after treatment.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions similar to other flavonoids since participants with known allergies to flavonoids are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 80 years old.
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I have been diagnosed with carpal tunnel syndrome in one or both hands.
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I have had numbness or tingling in my fingers for over 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is severely impaired.
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My blood counts are outside the normal range, indicating possible poor nutrition.
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I have an invasive fungal infection.
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I have an active hepatitis B or C infection.
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I am HIV positive.
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I am not currently in a study with Fisetin or taking flavonoid supplements.
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I have a new or active cancer, not including non-melanoma skin cancers.
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I have had surgery for carpal tunnel syndrome on my study hand.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in CTS symptoms
Secondary study objectives
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

Side effects data

From 2023 Phase 2 trial • 74 Patients • NCT04313634
10%
Pain in extremity
3%
Vertigo
3%
Menorrhagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Untreated Control Group
Dasatinib Plus Quercetin Treatment Goup
Fisetin Treatment Group

Trial Design

1Treatment groups
Experimental Treatment
Group I: Carpal Tunnel SyndromeExperimental Treatment1 Intervention
Adult men and women who have a clinical diagnosis for Carpal Tunnel Syndrome (CTS) will receive Fisetin for 2 day periods for 2 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
Not yet FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Carpal Tunnel Syndrome (CTS) often focus on reducing inflammation and oxidative stress, which are key contributors to nerve compression and damage in CTS. Anti-inflammatory medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), work by inhibiting enzymes involved in the inflammatory process, thereby reducing swelling and pain. Corticosteroid injections are another common treatment that reduces inflammation by suppressing the immune response. Antioxidants, like those being studied in Fisetin, help to neutralize free radicals and reduce oxidative stress, potentially protecting nerve cells from damage. These mechanisms are crucial for CTS patients as they directly address the underlying causes of nerve compression and inflammation, providing relief from symptoms and preventing further nerve damage.
Cold therapy to prevent paclitaxel-induced peripheral neuropathy.

Find a Location

Who is running the clinical trial?

Peter C. Amadio, M.D.Lead Sponsor
Peter C AmadioPrincipal InvestigatorMayo Clinic
Peter C Amadio, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Carpal Tunnel Syndrome
20 Patients Enrolled for Carpal Tunnel Syndrome

Media Library

Fisetin (Flavonoid) Clinical Trial Eligibility Overview. Trial Name: NCT05416515 — Phase 2
Carpal Tunnel Syndrome Research Study Groups: Carpal Tunnel Syndrome
Carpal Tunnel Syndrome Clinical Trial 2023: Fisetin Highlights & Side Effects. Trial Name: NCT05416515 — Phase 2
Fisetin (Flavonoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05416515 — Phase 2
~3 spots leftby Dec 2024