Capsaicin 179 mg patch versus oral Duloxetine in patients with chemotherapy-induced peripheral neuropathy: a phase 3 randomized multicentric open-label study (CAPNEUCHIM) - ICO-2022-02

Institut De Cancerologie De L Ouest0 个研究点目标入组 274 人开始时间: 2023年5月16日最近更新: 2024年7月22日

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•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 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

•Presence of known carcinomatous meningitis, Patient unable to undergo regular medical follow-up for geographical, social or psychological, 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)

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