Urea cream as prophylaxis for Capecitabine induced Hand Foot Syndrome: a Randomized phase 3 trial at a tertiary care hospital in South India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- to assess the efficacy of urea cream vs placebo to
研究概览
简要总结
Hand Foot Syndrome(HFS) is a well known adverse effect of Capecitabine, with rates ranging between 22%-735, as per various studies. Although not life threatening, it is associated with severe discomfort and impairment of quality of life, which is why addressing HFS is important. There is no well established prophylaxis for HFS. Our study aims to assess the efficacy of Urea cream to prevent Capecitabine induced HFS. Patients will be randomized into 2 arms. Patients in Arm A will be instructed to used 12% urea cream three times daily on hands and feet, as well as after washing. Patients in Arm B will be kept on observation. Primary objective of the study is to assess the efficacy of urea cream vs placebo to prevent HFS of any grade within a 6-week period. Secondary objectives include time to development of HFS, time to capecitabine dose interruption, evaluation of capecitabine dose intensity, quality of life analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with gastrointestinal malignancies of breast cancer initiating capecitabine treatment at a dose of at least 1000mg/m2 twice daily as monotherapy or combination therapy, ECOG PS less than 3, adequate bone marrow function.
排除标准
- •Patients with any dermatological toxicity other than alopecia that has not resolved, creatinine clearance of <30ml/min as per Cockcroft gault formula.
结局指标
主要结局
to assess the efficacy of urea cream vs placebo to
时间窗: at baseline, 3 weeks and 6 weeks
prevent HFS of any grade within a 6-week period.
时间窗: at baseline, 3 weeks and 6 weeks
次要结局
- time to development of HFS(time to capecitabine dose interruption,)