This study aims to compare the analgesic activity of capsaicin patch 8% applications at 3 months interval each on the cervico-facial area versus a reference neuropathic treatment with amitriptyline in patients with head and neck cancer in remission and with sequelae neuropathic pain. In this phase II trial, patients will be assigned in one of the two treatment arms: * Arm A (Experimental arm): Capsaïcin patch (Qutenza®) * Arm B (standard arm): Amitriptyline (Laroxyl®) 130 patients will be included and will be followed during 9 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).
Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.
INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers
Angers, France
Institut Sainte-Catherine
Avignon, France
Hôpital Saint-Joseph
Marseille, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
Pain will be assessed using a numerical scale from 0 to 10.
Time frame: 9 months for each patient
Neuropathic pain according to the Neuropathic Pain Symptom Inventory (NPSI) questionnaire.
Time frame: 9 months for each patient
Adverse events of the drugs evaluated using the NCI-CTC AE V5.
Time frame: 9 months for each patient
Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30).
Time frame: 9 months for each patient
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