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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.