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Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.
Sponsor: Institut Claudius Regaud
Summary
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.
Official title: Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2021-04-28
Completion Date
2025-04-28
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
Capsaïcin patch (Qutenza®)
Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).
Amitriptyline (Laroxyl®)
Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.
Locations (4)
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