What side effects are associated with this type of intervention?

Common treatments for Carpal Tunnel Syndrome (CTS) include corticosteroid injections and nonsteroidal anti-inflammatory drugs (NSAIDs). Corticosteroid injections can provide temporary relief but may cause side effects such as increased blood sugar levels, local infection, and weakening of tendons and ligaments with repeated use. NSAIDs, while helpful in reducing inflammation and pain, can lead to gastrointestinal issues such as ulcers and bleeding, as well as kidney problems with long-term use. Both treatments aim to reduce inflammation, similar to the properties of Fisetin being studied.

What prior FDA approvals exist?

The FDA has approved various treatments for Carpal Tunnel Syndrome, primarily focusing on anti-inflammatory approaches. Commonly used treatments include corticosteroid injections, which reduce inflammation and alleviate symptoms. Nonsteroidal anti-inflammatory drugs (NSAIDs) are also frequently used to manage pain and inflammation. While specific antioxidant treatments like Fisetin have not been widely approved for CTS, the ongoing research into Fisetin's efficacy highlights the potential for new therapeutic options that combine anti-inflammatory and antioxidant properties.

What other types of research exist?

Promising, novel alternatives to Fisetin for Carpal Tunnel Syndrome patients include: 1) Dexamethasone and Triamcinolone injections, which have been used for idiopathic trigger finger and may offer anti-inflammatory benefits. 2) Sorbinil, an aldose reductase inhibitor, which has shown improvement in joint mobility and strength in diabetic patients with limited joint mobility. 3) Gold-coated superparamagnetic iron oxide nanoparticles (AuSPION), which have demonstrated significant clinical improvements in reducing inflammation and edema in arthritis models.

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Flavonoid

Fisetin for Carpal Tunnel Syndrome

Q: What is the mechanism of action of this treatment?

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.

Phase 2

Waitlist Available

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

No Placebo-Only Group

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.

Select...

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.

Select...

I am not currently in a study with Fisetin or taking flavonoid supplements.

Select...

I have a new or active cancer, not including non-melanoma skin cancers.

Select...

I have had surgery for carpal tunnel syndrome on my study hand.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 180 days

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 1 & 2 trial • 75 Patients • NCT04210986

38%

Arthralgia

15%

Pain in Extremity

12%

Lab Findings

12%

Nausea

Fatigue

Back Pain

Headache

Muscle Cramp

Dry Mouth

Flatulence

Rash Maculo-Papular

Covid 19

Neoplasms

Bladder Perforation

Rotator Cuff Injury

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fisetin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met

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.