Capsaicin patch compared to oral duloxetine for chemotherapy-induced nerve pain

Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy : a Phase 3 Randomized Multicentric Open-label Study.

This study is testing whether a capsaicin patch or an oral medication called duloxetine works better to relieve nerve pain in cancer patients who have had chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Cancerologie de l'Ouest (other)
• Drugs / interventions: imatinib, chemotherapy
• Locations: 11 sites (Angers and 10 other locations)
• Trial ID: NCT05840562 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a capsaicin patch versus oral duloxetine in treating chemotherapy-induced peripheral neuropathy (CIPN), a painful condition affecting many cancer patients after neurotoxic chemotherapy. Participants will be patients experiencing painful symptoms such as numbness and tingling in a 'gloves and socks' distribution, with a pain score of 4 or higher. The study aims to determine which treatment provides better relief from CIPN symptoms, with a focus on those whose symptoms persist after chemotherapy. The trial is designed as a phase 3 interventional study to provide robust data on treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with painful CIPN symptoms persisting for at least one month after chemotherapy with taxanes or platinum salts.

Not a fit: Patients with known carcinomatous meningitis or those who have pre-existing neuropathies unrelated to chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients suffering from debilitating nerve pain due to chemotherapy.

How similar studies have performed: Previous studies have shown positive results for duloxetine in treating CIPN, but the use of a capsaicin patch in this context is a novel approach.

Eligibility criteria

Inclusion Criteria:

* Patient with CIPN manifested by painful symptoms such as numbness and / or tingling and / or burning pain in fingers / hands and toes / feet with a typical distribution in "gloves and socks" beginning after neurotoxic chemotherapy
* Painful CIPN as expressed by the BPI-SF (average pain) as ≥ 4/10
* CIPN persisting at least 1 month after completion of chemotherapy with taxanes and/or platinum salts and sensory CIPN grade ≥ 2 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE v.5.0) grading scale
* Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs)
* Healthy and non-irritated skin on the areas to be treated
* Absence of neurotoxic chemotherapy planned during the next 6 months after inclusion
* Patient affiliated to a social security scheme
* \> 18 years old
* Signed written informed consent form

Exclusion Criteria:

* Presence of known carcinomatous meningitis
* Pre-existing known peripheral neuropathy of another aetiology (alcohol, diabetes, …)
* Hypersensitivity to Capsaicin or contra-indications to duloxetine (e.g imatinib, tamoxifen)
* Patient already treated for this neuropathy with Capsaicin patches
* Patient treated by antidepressant drugs at time of inclusion
* Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (\<3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)
* Patients with known severe renal or hepatic failure
* Breastfeeding or pregnant women
* Persons deprived of liberty or guardianship (including curatorship)
* Patient unable to undergo regular medical follow-up for geographical, social or psychological.

Where this trial is running

Angers and 10 other locations

• Institut de Cancérologie de l'Ouest — Angers, France (RECRUITING)
• CHU Bordeaux — Bordeaux, France (RECRUITING)
• Centre François Baclesse — Caen, France (RECRUITING)
• CHU Grenoble — Grenoble, France (RECRUITING)
• Polyclinique Chenieux — Limoges, France (RECRUITING)
• Centre Léon Bérard — Lyon, France (RECRUITING)
• "L'Hôpital Privé du Confluent " — Nantes, France (RECRUITING)
• Centre Antoine Lacassagne — Nice, France (RECRUITING)
• Institut de Cancérologie de l'Ouest — Saint-Herblain, France (RECRUITING)
• Institut de Cancérologie Strasbourg Europe — Strasbourg, France (RECRUITING)
• Institut Claudius Regaud -IUCT-O — Toulouse, France (RECRUITING)

Study contacts

• Study coordinator: François Xavier PILOQUET, MD

Conditions: Chemotherapy-induced Peripheral Neuropathy