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NCT04704453CompletedPhase 2

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

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.

Source: ClinicalTrials.gov · Last updated 14 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
13 (actual)
First submitted
8 Jan 2021
Start date
28 Apr 2021
Primary completion date
28 Apr 2025
Lead sponsor
Institut Claudius Regaud
NCT number
NCT04704453
EU CT number
2024-515510-41-00
EudraCT number
2020-003965-21

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 13
  • From 28 Apr 2021 to the primary completion date, 28 Apr 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other concomitant neoplasia (progressive or not).
  • Previous treatment with capsaicin or amitriptyline.
  • Topical treatment of the painful area used for more than 21 days before inclusion.

Other illness

  • ORL cancer in progression.
  • Allergy to any of the components of the capsaicin patch.
  • Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.
  • Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.

Other

  • Central etiology of pain.
  • Pain whose average intensity over the last 24 hours is assessed on the numerical scale as \< 2/10.
  • 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.
  • Ongoing opioid treatment \> 80mg/day oral morphine equivalent.
  • Patient included in another interventional therapeutic trial.
  • Pregnant or breastfeeding patient.
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut de Cancerologie de L'Ouest
Coordinator of this site? Confirm its status
AngersFranceCompleted
Sainte Catherine Institut Du Cancer Avignon-Provence
Coordinator of this site? Confirm its status
Avignon Cedex 9FranceCompleted
Hôpital Saint Joseph
Coordinator of this site? Confirm its status
MarseilleFranceCompleted
Oncopole Claudius Regaud
Coordinator of this site? Confirm its status
ToulouseFranceCompleted

This page is information, not medical advice. Discuss any trial with your doctor.