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COMPLETED
NCT04704453
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Capsaïcin patch (Qutenza®)

Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).

DRUG

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