Status:
COMPLETED
Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Previous treatment with capsaicin or amitriptyline.
- Topical treatment of the painful area used for more than 21 days before inclusion.
- Ongoing opioid treatment \> 80mg/day oral morphine equivalent.
- Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.
- Patient included in another interventional therapeutic trial.
- Pregnant or breastfeeding patient.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04704453
Start Date
April 28 2021
End Date
April 28 2025
Last Update
July 31 2025
Active Locations (4)
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1
INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers
Angers, France
2
Institut Sainte-Catherine
Avignon, France
3
Hôpital Saint-Joseph
Marseille, France, 13285
4
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France, 31059