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临床试验/NCT04659980
NCT04659980已完成不适用

Hilotherapy vs Frozen Gloves for Preventing Taxane-related Peripheral Neuropathy, Pain and Nail Toxicity in Breast Cancer

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年6月20日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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