NCT04659980已完成不适用
Hilotherapy vs Frozen Gloves for Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity in Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)
研究概览
简要总结
The prevention of taxane-related toxicities at the extremities is highly important for patients' treatment and quality-of-life. Unlike standard cryotherapy with frozen gloves, hilotherapy produces cooling at a constant temperature. Comparative data with frozen gloves are unavailable. This prospective self-controlled study explores the efficacy of hilotherapy at the right hand and foot compared to frozen gloves at the left in patients with early breast cancer treated with weekly paclitaxel 80 mg/m² or three-weekly docetaxel 75 mg/m².
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •adult (≥18 years) patients with breast cancer
- •treated with weekly paclitaxel 80 mg/m² (12 cycles) or three-weekly docetaxel 75 mg/m² (4 or 6 cycles) in an adjuvant or neo-adjuvant setting.
排除标准
- •peripheral neuropathy or pain in the extremities at baseline, regardless of whether this was related to a prior chemotherapy treatment or another condition
- •Raynaud's phenomenon, cold intolerance or any condition to the nails or peripheral blood vessels that could pose a risk to the compliance with the study interventions
- •insufficient understanding of the Dutch language for self-reporting the side-effects under investigation
- •Patients were excluded from the analysis if they received less than two thirds of planned treatment cycles, for other reasons than the side-effects investigated in this study.
研究组 & 干预措施
hilotherapy
Active Comparator
干预措施: hilotherapy (Device)
frozen gloves
Active Comparator
干预措施: frozen gloves (Device)
结局指标
主要结局
any-grade incidence of side-effects at the extremities (peripheral neuropathy, pain, nail toxicity)
时间窗: 24 weeks
次要结局
- grade 2+ side-effects at the extremities (peripheral neuropathy, pain, nail toxicities)(24 weeks)
研究者
研究点 (1)
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