2024-515510-41-00招募中2 期
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 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年8月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
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.
次要结局
- 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.
研究者
Docteur Antoine BODEN
Scientific
Oncopole Claudius Regaud
研究点 (4)
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