Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
研究概览
简要总结
Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.
Primary objective:
Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.
Secondary objectives:
Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.
- •Patients aged 18 and older
- •Nail toxicity < grade 2 (CTC-AE version 3.0)
- •Informed patients with signed consent
排除标准
- •History of treatment with taxane
- •Raynaud syndrome
- •Distal metastasis in superior extremity
- •Nail diseases
- •Distal arteriopathy
- •Cold intolerance
- •Peripheral neuropathy>=2
- •Pregnancy, breast feeding
- •Unable to give informed consent
- •Unable to have a medical follow-up for social, geographical, family or psychological reasons
结局指标
主要结局
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
时间窗: 4 months
次要结局
- Number of day between inclusion and apparition of nail toxicity(4 months)
- Necessity of local care, existence of pains(4 months)
- Tolerance and compliance for the frozen glove(4 months)