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

Conditions: Head and neck cancer
MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2020-003965-21-FR

Lead Sponsor: INSTITUT CLAUDIUS REGAUD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

1.Age = 18 years
2.ORL cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments.
3.Pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment.
4.Peripheral neuropathic character of pain objectified to a score = 4/10 on the DN4 questionnaire.
5.Pain whose average intensity over the last 24 hours is assessed on the numerical scale as = 2/10.
6.Patient affiliated to a Social Health Insurance in France.
7.Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria:
1.ORL cancer in progression
2.Other concomitant neoplasia (progressive or not).
3.Central etiology of pain.
4.Pain whose average intensity over the last 24 hours is assessed on the numerical scale as < 2/10.
5.Allergy to any of the components of the capsaicin patch.
6.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.
7.Contraindication to amitriptyline treatment.
8.Previous treatment with capsaicin or amitriptyline.
9.Topical treatment of the painful area used for more than 21 days before inclusion.
10.Ongoing opioid treatment > 80mg/day oral morphine equivalent.
11.Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.
12.Patient included in another interventional therapeutic trial .
13.Pregnant or breastfeeding patient.
14.Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
15.Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

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: The secondary objectives of the study are :<br>- A sensitivity study to assess the influence of managing pain other than neuropathic pain<br>- Compare safety and tolerance between treatment arms<br>- To compare the evolution of neuropathic pain between treatment arms<br>- 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. ;Timepoint(s) of evaluation of this end point: 9 months for each patient

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The Secondary Outcome Measures are:<br>- 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.<br>- Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014).<br>- Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5.<br>- Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.;Timepoint(s) of evaluation of this end point: 9 months for each patient

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