NCT03557554终止不适用
A Prospective Feasibility Study Investigating Primary Preventive Ability of Massage Therapy of Paclitaxel-Induced Peripheral Neuropathy in Patients With Newly Diagnosed Breast Cancer Scheduled to Undergo a Paclitaxel Based Regimen
Bryan Schneider2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年2月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer
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
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer diagnosis 2) Planning to receive chemotherapy treatment with paclitaxel in the curative setting (adjuvant or neoadjuvant) on a weekly or bi-weekly schedule
排除标准
- •Diabetes or other neurological disorder 2) Current or previous peripheral neuropathy 3)Previous treatment with paclitaxel 4)Active deep vein thrombosis (DVT) within last 12 months or history of untreated lower extremity DVT
研究组 & 干预措施
Massage Therapy
Experimental
Subjects who are planning treatment with paclitaxel as part of their standard of care treatment will receive a 20 minute massage prior to each paclitaxel infusion.
干预措施: Massage (Other)
结局指标
主要结局
Feasibility of Recruitment
时间窗: 1 year
rate of enrollment
Feasibility of Retention
时间窗: 1 year
rate of drop out or consent withdraw
次要结局
- Incidence of paclitaxel induced peripheral neuropathy(10 months)
- Severity of paclitaxel induced peripheral neuropathy(10 months)
- Rate of pharmacological interventions(10 months)
- Paclitaxel dose modification(4 months)
研究者
Bryan Schneider
Principal Investigator
Indiana University
研究点 (2)
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