NL-OMON53741招募中不适用
A comparison between Qutenza and duloxetine for the treatment of painful chemotherapy-induced peripheral neuropathy (QULOX): a pragmatic randomized controlled trial - QULOX study
Amsterdam UMC0 个研究点目标入组 103 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age >= 18 years of age
- •- Presence of CIPN grade 1 or higher according to the NCIC-CTC
- •- Treatment with chemotherapy in the last 5 years
- •- Able to give oral and written informed consent
- •- Painful neuropathy with mean pain (1 week) score of >= 4
排除标准
- •- Peripheral neuropathy from other causes (e.g. carpal/tarsal tunnel syndrome,
- •radiculopathy,
- •spinal stenosis, brachial plexopathy)
- •- Leptomeningeal carcinomatosis
- •- Use of selective serotonin reuptake inhibitors, exchanging for medication
- •without interaction is
- •possible following expertise of the pain specialist anti-depressant
- •- 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 which is not replaceable and according
- •to the treating specialist not safe to combine with duloxetine
- •- Any condition that by the judgement of the investigator might interfere with
- •the investigation
- •- Previous treatment with Qutenza or duloxetine for CIPN
研究者
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