2024-515510-41-00
Active, not recruiting
Phase 2
Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With ORL Cancer in Remission and With Sequellae Neuropathic Pain.
Oncopole Claudius Regaud, Oncopole Claudius Regaud4 sites in 1 country130 target enrollmentStarted: August 13, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Oncopole Claudius Regaud, Oncopole Claudius Regaud
- Enrollment
- 130
- Locations
- 4
- Primary Endpoint
- The Primary Outcome Measure is 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 ORL cancer in remission and with neuropathic pain.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- 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.
- •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).
- •Other concomitant neoplasia (progressive or not).
- •Central etiology of pain.
Outcomes
Primary Outcomes
The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
Secondary Outcomes
- For the sensitivity analysis, the endpoint will be defined as the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. Pain will be assessed using a numerical scale. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures.
- Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014).
- Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5.
- Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.
Investigators
Docteur Antoine BODEN
Scientific
Oncopole Claudius Regaud
Study Sites (4)
Loading locations...
Similar Trials
Recruiting
Phase 3
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.Coccyx DisorderNeuropathic PainCoccygodyniaNCT06023706Nantes University Hospital188
Completed
Phase 2
Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.Head and Neck CancerNCT04704453Institut Claudius Regaud13
Completed
Phase 4
Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200Osteoarthritis, KneeNCT03124407Propella Therapeutics120
Terminated
Phase 3
Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal HerniotomyPersistent Pain After Inguinal HerniotomyNCT01699854Rigshospitalet, Denmark50
Not yet recruiting
Not Applicable
Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in CoccygodygniaCoccyx DisorderNCT05983263Nantes University Hospital106