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

40 Participants Needed

Trial Summary

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.

What evidence supports the effectiveness of the drug fisetin for treating carpal tunnel syndrome?

Research shows that fisetin has neuroprotective effects and can reduce cell death in nerve cells by activating certain protective pathways. This suggests it might help with nerve-related conditions like carpal tunnel syndrome by protecting nerve cells from damage. ^{1 2 3 4 5}

Is fisetin generally safe for humans?

Fisetin, a natural compound found in fruits and vegetables, has been studied for its antioxidant and anti-inflammatory properties in various conditions, including diabetes, neurodegenerative diseases, and cancer. While these studies suggest potential health benefits, they primarily involve animal models or cell cultures, and comprehensive human safety data is limited. Therefore, while fisetin appears promising, more research is needed to confirm its safety in humans. ^{2 4 6 7 8}

How is the drug fisetin unique for treating carpal tunnel syndrome?

Fisetin is unique because it is a natural compound found in fruits and vegetables with known antioxidant and anti-inflammatory properties, which may help reduce inflammation and nerve damage in carpal tunnel syndrome, unlike traditional treatments that often focus on pain relief or surgery. ^{1 4 6 8 9}

What is the purpose of this trial?

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.

Research Team

Peter C Amadio, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Citrus Naringenin Increases Neuron Survival in Optic Nerve Crush Injury Model by Inhibiting JNK-JUN Pathway. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Protective Effects of Fisetin Against 6-OHDA-Induced Apoptosis by Activation of PI3K-Akt Signaling in Human Neuroblastoma SH-SY5Y Cells. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Fisetin inhibits TNF-α-induced inflammatory action and hydrogen peroxide-induced oxidative damage in human keratinocyte HaCaT cells through PI3K/AKT/Nrf-2-mediated heme oxygenase-1 expression. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The flavonoid fisetin as an anticancer agent targeting the growth signaling pathways. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Small Molecule Fisetin Modulates Alpha-Synuclein Aggregation. [2021]

6. Netherlands 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Fisetin attenuates cerulein-induced acute pancreatitis through down regulation of JNK and NF-κB signaling pathways. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Fisetin Modulates Human Oral Squamous Cell Carcinoma Proliferation by Blocking PAK4 Signaling Pathways. [2022]

9. United States 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. [2023]