Prevention of Paclitaxel Neuropathy With Cryotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
研究概览
简要总结
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cryotherapy
Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.
干预措施: Cryotherapy (Other)
Cryotherapy
Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
时间窗: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
次要结局
- Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.(From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.)
研究者
Mary Wilkinson
Principle Investigator
Medical Oncology & Hematology Associates of Northern Virginia