Clinical trial NCT04704453: Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.
Official title: Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Neuropathic Pain
Capsaicin patch
Amitriptyline
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. ORL cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments.
3. Pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment.
4. Peripheral neuropathic character of pain objectified to a score ≥ 4/10 on the DN4 questionnaire.
5. Pain whose average intensity over the last 24 hours is assessed on the numerical scale as ≥ 2/10.
6. 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.
7. Patient affiliated to a Social Health Insurance in France.
8. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria:

1. ORL cancer in progression.
2. Other concomitant neoplasia (progressive or not).
3. Central etiology of pain.
4. Pain whose average intensity over the last 24 hours is assessed on the numerical scale as \< 2/10.
5. Allergy to any of the components of the capsaicin patch.
6. 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.
7. Contraindication to amitriptyline treatment.
8. Patient with an unhealed skin lesion on the area to be treated.
9. Previous treatment with capsaicin or amitriptyline.
10. Topical treatment of the painful area used for more than 21 days before inclusion.
11. Ongoing opioid treatment \> 80mg/day oral morphine equivalent.
12. Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.
13. Patient included in another interventional therapeutic trial.
14. Pregnant or breastfeeding patient.
15. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
16. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Primary outcomes:
measure: The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
timeFrame: 9 months for each patient
Secondary outcomes:
measure: Neuropathic pain according to the Neuropathic Pain Symptom Inventory (NPSI) questionnaire.
timeFrame: 9 months for each patient
measure: Adverse events of the drugs evaluated using the NCI-CTC AE V5.
timeFrame: 9 months for each patient
measure: Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30).
timeFrame: 9 months for each patient
Other outcomes:
Locations:
city: Angers
country: France
facility: INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
Study officials:
References: