Effectiveness of Hilotherapy for the Prevention of Oxaliplatin-induced Peripheral Neuropathy and Pain in the Treatment of Gastrointestinal Tumors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks
研究概览
简要总结
Effectiveness of hilotherapy for the prevention of oxaliplatin-induced peripheral neuropathy and pain in the treatment of gastrointestinal tumors: A randomized controlled trial.
详细描述
This study investigates whether constant cooling of the hands and feet using Hilotherm ChemoCare devices reduces the incidence of (severe) oxaliplatin-induced peripheral neuropathy and pain compared to standard care (i.e. no hand and foot cooling) in patients with gastrointestinal tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •18 years or older
- •Gastro-intestinal tumor, treated in UZ Leuven (University Hospitals of Leuven)
- •Starting oxaliplatin-based treatment
排除标准
- •Already grade 2 or higher peripheral neuropathy
- •For a more detailed list, see protocol.
结局指标
主要结局
Time until Grade 2 or higher patient-reported peripheral neuropathy after start of treatment in the first 12 weeks
时间窗: 12 weeks
Time-to-event analysis of Grade 2 or higher patient-reported peripheral neuropathy (severity scale, based on a patient-reported outcome questionnaire: "Patient-Reported Outcomes for Adverse Events" (PRO-CTCAE)). Outcome measurement value: percentage, absolute number, grade number. \-- PRO-CTCAE: patient-reported outcome scale that assesses adverse events (e.g. "pain" and "numbness \& tingling") on severity (5-point Likert scale 0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe", 4 = "Very severe") and interference with daily activities (0 = "Not at all", 1 = "A little bit", 2 = "Somewhat", 3 = "Quite a bit", 4 = "Very much"). We use the scale to assess the current experienced symptoms, and the scale has been translated to Dutch.
次要结局
- Secondary Outcome Measures regarding pain in hands and feet (eortc-qlq-cipn20)(24 weeks)
- Secondary Outcome Measures regarding pain in hands and feet (pro-ctcae)(24 weeks)
- Secondary Outcome Measures regarding comfort hilotherapy(24 weeks)
- Secondary Outcome Measures regarding peripheral neuropathy (pro-ctcae)(24 weeks)
- Secondary Outcome Measures regarding peripheral neuropathy (eortc-qlq-cipn20)(24 weeks)