Randomized Controlled Trial to Evaluate Efficacy of Urea-based Cream for Prevention of Capecitabine-associated Hand Foot Skin Reactions
试验速览
- 阶段
- 2 期
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- any HFS
研究概览
简要总结
Hand foot skin reaction (HFS) from capecitabine is one of the most common adverse events from capecitabine. Urea cream has been proved its benefit to prevent HFS from sorafenib. Prior study using urea cream prophylaxis in patients receiving capecitabine was negative. However, result from aformentioned study was reported primarily from result of first cycle capecitabine. Urea cream as a prevention of HFS from capecitabine has been used in clinical practice in Thailand according to expert's opinion. We conducted the study to evaluate wheter the urea cream can prevent HFS or severe HFS.
详细描述
The patients who is planned to receive capecitabine for at least 3 cycles were enrolled in the study. The patients were randomized to receive 10% urea cream or standard measure. The patients were followed until the end of capecitabine treatment. The patients reported their symptoms of HFS and other adverse events (AE) before starting new cycle of capecitabine. Physician record of HFS and other AE, dose modification of capecitabine and compliance were extracted. We will report incidence of any HFS, > grade 3 HFS, capecitabine interruption or delay or discontinuation and time to develop HFS among both arms. The results of the study will be used for optimal prophylactic measures in patients treated with capecitabine.
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
- Single (Outcomes Assessor)
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
- •patients who has plan to receive capecitabine at the dosage of at least 2000 mg/m2 D1-14 every 21 days for at least 3 cycles
排除标准
- •preexisting neuropathy which was severe than grade 2
- •history of allergy to urea cream
- •patients with previous use of capecitabine 2000 mg/m2
- •patients who has prior routinely used of urea cream
研究组 & 干预措施
urea cream
use 10% urea cream apply at both hands and feet twice a day from time of starting capecitabine
干预措施: Urea cream (Drug)
结局指标
主要结局
any HFS
时间窗: from starting capecitabine until 4 week after capecitabine discontinuation
incidence of any HFS
次要结局
- severe HFS(from starting capecitabine until 4 week after capecitabine discontinuation)
- time to develop severe HFS(from starting capecitabine until 4 week after capecitabine discontinuation)
- capecitabine interruption(from starting capecitabine until 4 week after capecitabine discontinuation)