Capsaicin Patch for Peripheral Neuropathy

Overseen By Saba Javed, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive dysfunction, Drug abuse, Infections, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the capsaicin patch treatment for peripheral neuropathy?

The capsaicin patch, known as Qutenza, has been shown to provide pain relief for various types of neuropathic pain, including postherpetic neuralgia and diabetic peripheral neuropathy. In studies, it offered significant pain relief and improved sleep quality for up to 12 weeks after a single application, and it was generally well tolerated with only mild skin reactions. ^{1 2 3 4 5}

Is the capsaicin patch (Qutenza) safe for humans?

The capsaicin patch (Qutenza) is generally considered safe for humans, as it has been widely used for various types of neuropathic pain. It is a topical treatment, which means it is applied to the skin, and this can help reduce the risk of side effects compared to medications taken by mouth. ^{1 2 5 6 7}

How is the Qutenza patch different from other treatments for peripheral neuropathy?

The Qutenza patch is unique because it contains a high concentration of capsaicin, which is a compound that targets specific pain receptors in the skin. It is applied directly to the skin for a short duration, providing targeted pain relief without the need for systemic medication, which can reduce the risk of side effects associated with oral drugs. ^{1 2 3 5 8}

What is the purpose of this trial?

To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.

Research Team

Saba Javed, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals experiencing pain from chemotherapy-induced peripheral neuropathy (CIPN). Specific eligibility criteria are not provided, but typically participants would need to have a diagnosis of CIPN and be in stable health otherwise.

Inclusion Criteria

I finished my chemotherapy within the last year.

I have long-term pain in my legs due to chemotherapy.

My pain level is 4 or higher on a scale of 0 to 10.

Exclusion Criteria

Participants with cognitive dysfunction

Participants with a recent history (<6 months) of drug or alcohol abuse

Pregnant participants

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 4 topical capsaicin patches applied on their feet for 30 minutes

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Qutenza Patch

Trial Overview The study is testing the effectiveness of a Qutenza patch, which contains capsaicin, to see if it can relieve pain associated with CIPN and improve how patients walk.

Participant Groups

Group I: Treatment with Qutenza Patch (Topical Capsaicin) Experimental Treatment 1 Intervention

Up to 4 topical capsaicin patches will be applied on your feet for 30 minutes.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Averitas Pharma, Inc.

Industry Sponsor

Trials

4

Recruited

630+

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of the feasibility of high-concentration capsaicin patches in the pain unit of a tertiary hospital for a population of mixed refractory peripheral neuropathic pain syndromes in non-diabetic patients. [2018]

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

Predictors of Response in Patients With Postherpetic Neuralgia and HIV-Associated Neuropathy Treated With the 8% Capsaicin Patch (Qutenza). [2022]

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

Qutenza (capsaicin) 8% patch onset and duration of response and effects of multiple treatments in neuropathic pain patients. [2014]

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

Capsaicin 8% Dermal Patch: A Review in Peripheral Neuropathic Pain. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Capsaicin 179-mg cutaneous patch in the treatment of post-surgical neuropathic pain: a scoping review of current evidence and place in therapy. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Capsaicin Cutaneous Patch: a Cost-consequences Study in a French University Hospital]. [2015]

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

High-Dose Capsaicin for the Treatment of Neuropathic Pain: What We Know and What We Need to Know. [2021]

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

Capsaicin 8 % Patch: A Review in Peripheral Neuropathic Pain. [2018]