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

Last updated: April 22, 2025
Sponsor: Institut Claudius Regaud
Overall Status: Active - Not Recruiting

Phase

2

Condition

Pain

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

Capsaïcin patch (Qutenza®)

Amitriptyline (Laroxyl®)

Clinical Study ID

NCT04704453
20 VADS 04
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years.

  2. ORL cancer in remission: absence of clinical or radiological signs of progression atleast 3 months after specific treatments.

  3. Pain of the cervico-facial sphere persisting for more than 3 months after surgicaland/or radiotherapy treatment.

  4. Peripheral neuropathic character of pain objectified to a score ≥ 4/10 on the DN4questionnaire.

  5. Pain whose average intensity over the last 24 hours is assessed on the numericalscale as ≥ 2/10.

  6. Postmenopausal patient or patient who agrees to use effective contraception for theduration of treatment and for a minimum of 15 days after the end of the treatmentperiod. Non-menopausal patients must have a negative pregnancy test prior toinclusion in the study.

  7. Patient affiliated to a Social Health Insurance in France.

  8. Patient who signed informed consent prior to inclusion in the study and prior to anyspecific study procedures.

Exclusion

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 numericalscale 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 precautionsdescribed in the protocol because of its proximity to mucous membranes or eyelids.

  7. Contraindication to amitriptyline treatment.

  8. Patient with an unhealed skin lesion on the area to be treated.

  9. Previous treatment with capsaicin or amitriptyline.

  10. Topical treatment of the painful area used for more than 21 days before inclusion.

  11. Ongoing opioid treatment > 80mg/day oral morphine equivalent.

  12. Uncontrolled high blood pressure or cardiovascular history (infarction, stroke,pulmonary embolism) less than 3 months ago.

  13. Patient included in another interventional therapeutic trial.

  14. Pregnant or breastfeeding patient.

  15. Any psychological, family, geographical or sociological condition that preventscompliance with the medical follow-up and/or procedures of the study protocol.

  16. Patient who has forfeited his/her freedom by administrative or legal award or who isunder legal protection (curatorship and guardianship, protection of justice).

Study Design

Total Participants: 13
Treatment Group(s): 2
Primary Treatment: Capsaïcin patch (Qutenza®)
Phase: 2
Study Start date:
April 28, 2021
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers

    Angers,
    France

    Site Not Available

  • Institut Sainte-Catherine

    Avignon,
    France

    Site Not Available

  • Hôpital Saint-Joseph

    Marseille, 13285
    France

    Site Not Available

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse, 31059
    France

    Site Not Available

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