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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a capsaicin patch, known as Qutenza, can reduce pain and improve walking in individuals with peripheral neuropathy (nerve damage) caused by certain cancer treatments. The patch is applied to the feet for 30 minutes and aims to ease discomfort. Individuals who have experienced persistent leg pain for more than three months after chemotherapy and completed their treatment within the last year may be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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.

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

Research has shown that the Qutenza Patch, which contains capsaicin, relieves pain in various conditions. Studies have found it can significantly reduce pain and improve the quality of life for those with nerve pain.

However, users should be aware of possible side effects. Common issues include pain, sensitivity, and numbness at the application site. Less common reactions, affecting fewer than 1% of users, include irregular heartbeats, itchy eyes, and a faster heart rate.

The FDA has already approved the Qutenza Patch for other uses, indicating a certain level of established safety. It is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for peripheral neuropathy that often involve oral medications or injections, the Qutenza Patch offers a unique delivery method by applying capsaicin directly to the skin. Capsaicin, derived from chili peppers, works by desensitizing nerve receptors responsible for transmitting pain. Researchers are excited about this approach because it targets pain locally and could potentially provide relief without the systemic side effects commonly seen with oral drugs. This localized treatment might also offer quicker pain relief, which is a significant advantage for patients seeking fast-acting solutions.

What evidence suggests that the Qutenza Patch might be an effective treatment for peripheral neuropathy?

Research has shown that the Qutenza Patch, which contains capsaicin, can help relieve certain types of nerve pain. Studies have found it reduces pain for people with postherpetic neuralgia (pain after shingles) and nerve pain related to HIV. For those with painful diabetic nerve damage, the patch significantly eases pain and improves sleep. In this trial, participants will receive treatment with the Qutenza Patch, which delivers a high amount of capsaicin directly to the skin, potentially reducing pain signals from the nerves. While these results are promising, more research is needed to confirm its effectiveness specifically for nerve pain caused by chemotherapy and its effect on walking. ^{1 3 6 7 8}

Who Is on the Research Team?

Saba Javed, M D

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23707278/

Efficacy of Qutenza® (capsaicin) 8% patch for neuropathic ... These results confirm that Qutenza is effective for the treatment of both PHN and HIV-AN compared to low-dose control patch. Keywords: Capsaicin; Neuropathic ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590016302449

Capsaicin 8% Patch in Painful Diabetic Peripheral ... Capsaicin 8% patch provided effective relief in painful diabetic peripheral neuropathy. · Improvements in sleep quality were modest and significant with ...

3. journals.lww.com journals.lww.com/painrpts/fulltext/2025/04000/narrative_review_of_the_efficacy_and_safety_of_the.3.aspx

Narrative review of the efficacy and safety of the... : PAIN ... The results show that the HC capsaicin patch consistently provides pain relief and improves quality of life for several pNeP conditions, with increasing ...

4. qutenzahcp.com qutenzahcp.com/dpn/clinical-results

DPN - Clinical Results | QUTENZA HCP In a Phase 3 clinical study, the percent change in average pain from baseline to Week 12 was -22% (±3%) for placebo and -30% (±3%) for QUTENZA. Approximately ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06540456

NCT06540456 | Qutenza 8% Capsaicin Topical System for ... Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11781771/

Narrative review of the efficacy and safety of the high ... The results show that the HC capsaicin patch consistently provides pain relief and improves quality of life for several pNeP conditions, with increasing ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/022395s019lbl.pdf

QUTENZA® (capsaicin) patch - accessdata.fda.gov Less common adverse reactions (<1%) with QUTENZA observed during PHN clinical trials included: palpitations, tachycardia, eye pruritus, application site ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26666418/

Capsaicin 8 % Patch: A Review in Peripheral Neuropathic ... In two randomized trials, a single 60-min application of the capsaicin 8 % patch reduced pain scores significantly more than a low-concentration (0.04 %) ...