Phase
Condition
Pain
Nasopharyngeal Cancer
Human Papilloma Virus (Hpv)
Treatment
Capsaïcin patch (Qutenza®)
Amitriptyline (Laroxyl®)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years.
ORL cancer in remission: absence of clinical or radiological signs of progression atleast 3 months after specific treatments.
Pain of the cervico-facial sphere persisting for more than 3 months after surgicaland/or radiotherapy treatment.
Peripheral neuropathic character of pain objectified to a score ≥ 4/10 on the DN4questionnaire.
Pain whose average intensity over the last 24 hours is assessed on the numericalscale as ≥ 2/10.
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.
Patient affiliated to a Social Health Insurance in France.
Patient who signed informed consent prior to inclusion in the study and prior to anyspecific study procedures.
Exclusion
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 numericalscale 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 precautionsdescribed 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 preventscompliance 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 isunder legal protection (curatorship and guardianship, protection of justice).
Study Design
Connect with a study center
INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers
Angers,
FranceSite Not Available
Institut Sainte-Catherine
Avignon,
FranceSite Not Available
Hôpital Saint-Joseph
Marseille, 13285
FranceSite Not Available
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059
FranceSite Not Available
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