NCT04704453
Completed
Phase 2
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.
Institut Claudius Regaud6 sites in 1 country13 target enrollmentStarted: April 28, 2021Last updated:
ConditionsHead and Neck Cancer
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Institut Claudius Regaud
- Enrollment
- 13
- Locations
- 6
- Primary Endpoint
- The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/
- •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 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/
- •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.
Arms & Interventions
Standard arm (B): amitriptyline
Other
Intervention: Amitriptyline (Laroxyl®) (Drug)
Experimental arm (A): capsaicin patch
Experimental
Intervention: Capsaïcin patch (Qutenza®) (Drug)
Outcomes
Primary Outcomes
The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
Time Frame: 9 months for each patient
Pain will be assessed using a numerical scale from 0 to 10.
Secondary Outcomes
- Quality of life evaluated according to the Quality of Life Questionnaire-Core 30 (QLQ-C30).(9 months for each patient)
- Neuropathic pain according to the Neuropathic Pain Symptom Inventory (NPSI) questionnaire.(9 months for each patient)
- Adverse events of the drugs evaluated using the NCI-CTC AE V5.(9 months for each patient)
Investigators
Study Sites (6)
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