A Comparison Between Qutenza and Duloxetine for the Treatment of Painful Chemotherapy-induced Peripheral Neuropathy: a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Average pain change
研究概览
简要总结
The primary objective is to determine whether in patients with CIPN pain, treatment with Qutenza has the same effect as treatment with duloxetine 60 mg daily.
详细描述
Rationale: Painful polyneuropathy occurs in approximately 20-40% of patients after the chemotherapy treatment and has a negative influence on quality of life. To our knowledge, no previous randomized study examined Qutenza in patients with CIPN, and no study compared Qutenza to duloxetine. We hypothesize that the effect of Qutenza on the severity of pain and its impact on functioning is the same as that of duloxetine in patients with CIPN, as measured by the numeric rating scale (NRS).
Objective: The primary objective is to determine whether in patients with CIPN pain, treatment with Qutenza has the same effect as treatment with duloxetine 60 mg daily.
Study design: The study is a pragmatic randomized controlled trial.
Study population: Patients who have been treated with chemotherapy in the last 5 years to 3 months and with CIPN grade 1 or higher according to the NCIC-CTC (National Cancer Institute of Canada-Common Toxicity Criteria). The patients are ≥ 18 years of age and have to experience painful neuropathy longer than 3 months with mean (1 week) pain score of ≥4.
Intervention: The affected extremity or extremities will be treated with Qutenza (179mg) according to normal procedures of the hospital and as recommended by the manufacturer.
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
- Single (Investigator)
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 of age
- •Presence of CIPN grade 1 or higher according to the NCIC-CTC
- •Mean pain (1 week) score of ≥ 4
- •Treatment with chemotherapy in the last 5 years
- •Able to give oral and written informed consent
- •Painful neuropathy longer than three months
排除标准
- •Peripheral neuropathy from other causes (e.g. carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
- •Leptomeningeal carcinomatosis
- •Severe depression or use of anti-depressant medication
- •Psychiatric disorders which can interfere with cooperation
- •Abnormal renal (< GFR 30) or liver function tests (> 2 times normal value)
- •Severe heart failure as determined by the cardiologist
- •Allergy for duloxetine or capsaicin
- •Skin diseases in hands and/or feet, damaged skin
- •The presence of uncontrolled/untreated hypertension
- •Concomitant use of medication that may interact with duloxetine such as fluvoxamine, ciprofloxacin and enoxacin
- •Active cancer treatment (such as radiotherapy or chemotherapy)
- •Active cancer
- •Previous treatment with Qutenza or duloxetine for CIPN
- •Any condition that by the judgement of the investigator might interfere with the investigation
研究组 & 干预措施
Patients with chemotherapy-induced peripheral neuropathy who receive Qutenza
干预措施: Qutenza (Drug)
Patients with chemotherapy-induced peripheral neuropathy who receive Duloxetine
干预措施: Duloxetine (Drug)
结局指标
主要结局
Average pain change
时间窗: 12 weeks
As measured by the Brief Pain Inventory, a scale from 0 to 10, with 0 is no pain at all, and 10 is worst pain you can imagine
次要结局
- Pain at 6 weeks after the start of treatment(6 weeks)
- Quality of life score(12 weeks)
- Pain interference score(12 weeks)
- Patient satisfaction(12 weeks)
- Side effect profile(12 weeks)
研究者
Emma Cassee, MD
Coordinating investigator/project leader
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)