Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and … (NCT04704453) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.
France13 participantsStarted 2021-04-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
✕. 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.