NCT04704453已完成2 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- 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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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.
- •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.
- •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).
研究组 & 干预措施
Standard arm (B): amitriptyline
Other
干预措施: Amitriptyline (Laroxyl®) (Drug)
Experimental arm (A): capsaicin patch
Experimental
干预措施: Capsaïcin patch (Qutenza®) (Drug)
结局指标
主要结局
The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
时间窗: 9 months for each patient
Pain will be assessed using a numerical scale from 0 to 10.
次要结局
- 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)
研究者
研究点 (6)
Loading locations...
相似试验
招募中
3 期
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.Coccyx DisorderNeuropathic PainCoccygodyniaNCT06023706Nantes University Hospital188
已完成
不适用
A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic PainPost-operative Peripheral Neuropathic PainNCT02171182Astellas Pharma s.r.o.319
终止
3 期
Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal HerniotomyPersistent Pain After Inguinal HerniotomyNCT01699854Rigshospitalet, Denmark50
已完成
不适用
Capsaicin 8% Patch for Spinal Cord Injury Neuropathic PainSpinal Cord InjuriesNeuropathic PainNCT02441660The University of Texas Health Science Center at San Antonio11
已完成
2 期
Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)Delayed Onset Muscle SorenessNCT02602353Lead Chemical Co., Ltd.42