Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With ORL Cancer in Remission and With Sequellae Neuropathic Pain.

Phase 1

Recruiting

• Conditions: Head and neck cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-515510-41-00
• Lead Sponsor: Oncopole Claudius Regaud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-14
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Age = 18 years, ORL cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments., Pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment., Peripheral neuropathic character of pain objectified to a score = 4/10 on the DN4 questionnaire., Pain whose average intensity over the last 24 hours is assessed on the numerical scale as = 2/10., Postmenopausal patient or patient who agrees to use effective contraception for the duration of treatment and for a minimum of 15 days after the end of the treatment period. Non-menopausal patients must have a negative pregnancy test prior to inclusion in the study., Patient affiliated to a Social Health Insurance in France., Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria

ORL cancer in progression., Topical treatment of the painful area used for more than 21 days before inclusion., Ongoing opioid treatment > 80mg/day oral morphine equivalent., Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago., Patient included in another interventional therapeutic trial., Pregnant or breastfeeding patient., Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol., Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)., Other concomitant neoplasia (progressive or not)., Central etiology of pain., Pain whose average intensity over the last 24 hours is assessed on the numerical scale as < 2/10., Allergy to any of the components of the capsaicin patch., Capsaicin patch not applicable to the area to be treated despite the precautions described in the protocol because of its proximity to mucous membranes or eyelids., Contraindication to amitriptyline treatment., Patient with an unhealed skin lesion on the area to be treated., Previous treatment with capsaicin or amitriptyline.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 ORL cancer in remission and with neuropathic pain.;Secondary Objective: A sensitivity study to assess the influence of managing pain other than neuropathic pain, Compare safety and tolerance between treatment arms, To compare the evolution of neuropathic pain between treatment arms, Compare quality of life between treatment arms;Primary end point(s): The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):For the sensitivity analysis, the endpoint will be defined as 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. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures.;Secondary end point(s):Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014).;Secondary end point(s):Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5.;Secondary end point(s):Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.