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Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy

RecruitingPhase 3Ages 18 Years - anyAllInstitut Cancerologie de l'Ouest
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In plain words

What the trial is, and whether it could suit you

Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and disabling complication of systemic chemotherapy, particularly with oxaliplatin or taxanes. The incidence of CIPN is variable but approximately 30-40% of patients treated with neurotoxic chemotherapy agents develop CIPN after long-term use of taxanes or oxaliplatin. This CIPN is essentially a sensory peripheral neuropathy with pain manifested by unpleasant symptoms such as numbness, tingling, and less frequently shooting/burning pain. These symptoms spread proximally to affect both lower and upper extremities in a characteristic "stocking and glove" distribution. Many symptoms of CIPN may resolve completely for some patients. However, CIPN is only partly reversible for most. In the worst instances, it does not appear to be reversible at all and can even increase over time. CIPN is difficult to manage. Only duloxetine i

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Capsaicin
  • Duloxetine
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Where

11 sites
Institut de Cancérologie de l'Ouest
Angers, France
CHU Bordeaux
Bordeaux, France
Centre François Baclesse
Caen, France
CHU Grenoble
Grenoble, France
Polyclinique Chenieux
Limoges, France
Centre Léon Bérard
Lyon, France
"L'Hôpital Privé du Confluent "
Nantes, France
Centre Antoine Lacassagne
Nice, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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