Fisetin for Carpal Tunnel Syndrome

Overseen By Lindsey Hobbs

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Peter C. Amadio, M.D.

Must not be taking: Flavonoids

Disqualifiers: Pregnancy, Liver disease, Uncontrolled diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 60

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the safety and effectiveness of the drug Fisetin for individuals with mild or moderate carpal tunnel syndrome (CTS). Participants will receive Fisetin to determine its impact on symptoms like numbness or tingling in the fingers. The trial seeks individuals who have experienced these symptoms for at least four weeks and have a clinical diagnosis of CTS. Those who have not had recent surgery or injections for CTS may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial may require you to stop taking certain medications if they are listed in the Investigator Brochure, but it depends on whether they can be safely paused. If you need to start any of these medications during the study, your participation will be reassessed.

Is there any evidence suggesting that Fisetin is likely to be safe for humans?

Research has shown that Fisetin has been promising in animal studies, where it reduced certain cells that can cause problems as we age. This suggests potential benefits, but more research is needed to understand its effects on humans. Previous clinical trials have examined Fisetin's safety, but detailed information on its safety for humans is still being collected.

Fisetin is currently being tested in a study for carpal tunnel syndrome, so its safety and effectiveness in people are still under evaluation. Since this trial is in an early phase, it primarily focuses on gathering safety information. Researchers are closely monitoring for any side effects or issues. While some early results might be available, confirming safety takes time. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for carpal tunnel syndrome?

Most treatments for Carpal Tunnel Syndrome, like wrist splinting, corticosteroid injections, or surgery, focus on relieving pressure on the median nerve. But Fisetin, a natural flavonoid found in fruits like strawberries, works differently by targeting inflammation and oxidative stress, which are key contributors to nerve damage. Researchers are excited about Fisetin because it offers a potentially safer, non-invasive alternative with antioxidant properties that could not only alleviate symptoms but also support nerve health. Unlike current options that may take longer to show effects or come with side effects, Fisetin has the potential to provide relief more quickly and with fewer risks.

What evidence suggests that Fisetin might be an effective treatment for carpal tunnel syndrome?

Research suggests that fisetin, the treatment under study in this trial, might help treat carpal tunnel syndrome (CTS) by targeting certain damaged cells. These damaged cells, known as senescent cells, malfunction and can cause inflammation. Fisetin helps remove these cells, potentially reducing the inflammation and pain associated with CTS. Studies have shown that fisetin can help manage various chronic diseases by addressing these problematic cells. Although specific evidence on fisetin's effectiveness for CTS is still developing, its impact on these cells provides a strong basis for its potential benefits. ^{1 2 5 6 7}

Who Is on the Research Team?

Peter C Amadio, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman who can have children and have tested negative for pregnancy.

I will not donate eggs from the start of the study until 60 days after.

Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram

Exclusion Criteria

My kidney function is severely impaired.

My blood counts are outside the normal range, indicating possible poor nutrition.

I have a condition like nerve disease, kidney failure, liver disease, uncontrolled diabetes, or another metabolic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fisetin for 2-day periods over 2 months

8 weeks

Multiple visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Blood samples collected at baseline, 60 days, and 180 days

What Are the Treatments Tested in This Trial?

Interventions

• Fisetin

Trial Overview 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.

How Is the Trial Designed?

Group I: Carpal Tunnel Syndrome Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Peter C. Amadio, M.D.

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

Fisetin, a bioflavonoid found in fruits and vegetables, significantly reduced blood glucose and glycosylated hemoglobin levels in diabetic rats after 30 days of treatment at a dose of 10 mg/kg, while also increasing plasma insulin levels.

The study demonstrated that fisetin helps regulate carbohydrate metabolism by normalizing the activities of key enzymes in the liver and kidneys of diabetic rats, suggesting its potential as a therapeutic agent for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulatory effects of fisetin, a bioflavonoid, on hyperglycemia by attenuating the key enzymes of carbohydrate metabolism in hepatic and renal tissues in streptozotocin-induced diabetic rats. Prasath, GS., Subramanian, SP.[2021]

Fisetin, a flavonol found in various fruits and vegetables, has demonstrated the ability to inhibit cancer cell growth in laboratory studies and in animal models, suggesting its potential as a cancer treatment.

The compound works by targeting key components of cell signaling pathways that regulate cell survival, apoptosis, and tumor growth, highlighting its multifaceted mechanism of action in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The flavonoid fisetin as an anticancer agent targeting the growth signaling pathways. Rengarajan, T., Yaacob, NS.[2021]

Fisetin, a natural compound found in fruits and vegetables, significantly inhibits the growth and DNA synthesis of human colon cancer cells (HT-29), with a 79% reduction in cell number observed after 72 hours at a concentration of 60 micromol/L.

The mechanism of action involves disrupting cell cycle progression, particularly causing a G(1) to S phase arrest and a G(2)/M phase block, which is linked to decreased activity of cyclin-dependent kinases (CDK) and changes in retinoblastoma protein phosphorylation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fisetin inhibits the activities of cyclin-dependent kinases leading to cell cycle arrest in HT-29 human colon cancer cells. Lu, X., Jung, Ji., Cho, HJ., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05416515

A Study of Fisetin to Treat Carpal Tunnel Syndrome This research study is being conducted to investigate the safety and effectiveness of the drug Fisetin for mild or moderate carpal tunnel syndrome (CTS).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0047637424000952

Fisetin as a senotherapeutic agent: Evidence and ... Our review of available data suggests that targeting senescent cells with fisetin offers a promising strategy for managing multiple chronic diseases.

3. ors.org ors.org/wp-content/uploads/AM24/Tendon/97.pdf

Fisetin Senolytic Therapy Targets Cellular Senescence in ... Fisetin Senolytic Therapy Targets Cellular Senescence in Carpal Tunnel Syndrome. Lissa Mizutani*, William Kelly*, Claire Desrochers, Penn Sagedahl, Ken ...

4. clinicaltrial.be clinicaltrial.be/en/details/16580?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

A Study of Fisetin to Treat Carpal Tunnel Syndrome - Clin... Adult men and women who have a clinical diagnosis for Carpal Tunnel Syndrome (CTS) will receive Fisetin for 2 day periods for 2 months.

5. mayo.edu mayo.edu/research/clinical-trials/cls-20532377

A Study of FIsetin to Treat CArpal Tunnel Syndrome 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 ...

6. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Fisetin

Fisetin | C15H10O6 | CID 5281614 - PubChem - NIH Molecular Formula. C15H10O ; Synonyms. Fisetin; 528-48-3; 2-(3,4-Dihydroxyphenyl)-3,7-dihydroxy-4H-chromen-4-one; 5-Desoxyquercetin; 3,3',4',7- ...

7. go.drugbank.com go.drugbank.com/drugs/DB07795

Fisetin: Uses, Interactions, Mechanism of Action 2-(3,4-Dihydroxyphenyl)-3,7-dihydroxy-4H-1-benzopyran-4-one; 3,3',4',7-Tetrahydroxyflavone; 3,7,3',4'-tetrahydroxyflavone; 5-Desoxyquercetin; 7 ...