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Table 1 Inclusion and non-inclusion criteria

From: Study protocol of the TEC-ORL clinical trial: a randomized comparative phase II trial investigating the analgesic activity of capsaicin vs Laroxyl in head and neck Cancer survivors presenting with neuropathic pain sequelae

Inclusion Criteria

Non-Inclusion criteria

 - Age ≥ 18 years.

 - HN 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 as a score ≥ 4/10 on the DN4 questionnaire.

 - Average pain intensity over the past 24 hours 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.

 - HN cancer progression.

 - Other concomitant neoplasia (progressive or not).

 - Central pain etiology.

 - Average pain intensity over the past 24 hours is assessed on the numerical scale as < 2/10.

 - Allergy to any of the components of the capsaicin patch.

 - Capsaicin patch cannot be applied to the area to be treated despite taking the precautions described in the protocol because of proximity to mucous membranes or eyelids.

 - Contraindication of amitriptyline treatment.

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

 - Previous course of capsaicin or amitriptyline treatment.

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

 - Ongoing opioid treatment > 80 mg/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 through an administrative or judicial sentence or who is under legal custody (curatorship and guardianship, protection of justice).