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Capsaicin 179 mg patch versus oral Duloxetine in patients with chemotherapy-induced peripheral neuropathy: a phase 3 randomized multicentric open-label study (CAPNEUCHIM)
EU CTIS ID: 2023-504618-31-00
What this study is testing
To demonstrate that capsaicin 179 mg patch once compared to duloxetine daily, improves painful CIPN after a 5-week treatment period
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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
- 10. Patient consent to use contraception during treatment
- 2. Painful CIPN as expressed by the BPI-SF as ≥ 4/10
- 3. 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
- 4. Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs, topic treatment)
- 5. Healthy and non-irritated skin on the areas to be treated
You likely can't join if
- 1. Presence of known carcinomatous meningitis
- 8. Breastfeeding or pregnant women
- 9. Persons deprived of liberty or guardianship (including curatorship)
- 12. Patient treated by botulinum toxin A in subcutaneous within 30 days of inclusion.
- 10. Patient unable to undergo regular medical follow-up for geographical, social or psychological
- 11. Patient already treated by photo biomodulation at time of inclusion
See the full eligibility criteria
- 1. 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
- 10. Patient consent to use contraception during treatment
- 2. Painful CIPN as expressed by the BPI-SF as ≥ 4/10
- 3. 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
- 4. Stable doses in the 4 weeks before screening, of concomitant neuropathic pain medication (antiepileptic drugs, topic treatment)
- 5. Healthy and non-irritated skin on the areas to be treated
- 6. Absence of neurotoxic chemotherapy planned during the next 6 months after inclusion
- 7. Patient affiliated to a social security scheme
- 8. ≥ 18 years old
- 9. Signed written informed consent form
- 1. Presence of known carcinomatous meningitis
- 8. Breastfeeding or pregnant women
- 9. Persons deprived of liberty or guardianship (including curatorship)
- 12. Patient treated by botulinum toxin A in subcutaneous within 30 days of inclusion.
- 10. Patient unable to undergo regular medical follow-up for geographical, social or psychological
- 11. Patient already treated by photo biomodulation at time of inclusion
- 2. Pre-existing known peripheral neuropathy of another aetiology (alcohol, diabetes, …)
- 3. Hypersensitivity to Capsaicin or contra-indications to duloxetine (e.g imatinib, tamoxifen)
- 4. Patient already treated for this neuropathy with Capsaicin patches
- 5. Patient treated by antidepressant drugs belonging to the SSRI or SNRI within 30 days of prior to inclusion Exception: Patients receiving mirtazapine or mianserin may be included provided that: the dose has been stable for at least 4 weeks before inclusion
- 6. Known 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)
- 7. Patients with known severe renal or hepatic failure
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.