Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.

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.

Timeline

Start

2021-04-28

Primary completion

2025-04-28

Completion

2025-04-28

Publications

• Background Boden A, Lusque A, Lodin S, Bourgouin M, Mauries V, Moreau C, Fabre A, Mounier M, Poublanc M, Caunes-Hilary N, Filleron T. Study protocol of the TEC-ORL clinical trial: a randomized comparative phase II trial investigating the analgesic activity of capsaicin vs Laroxyl in head and neck Cancer survivors presenting with neuropathic pain sequelae. BMC Cancer. 2022 Dec 5;22(1):1260. doi: 10.1186/s12885-022-10348-2.

Drugs

Indications