A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 598
- 主要终点
- Hand-foot syndrome onset
研究概览
简要总结
This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •adult patients, >=18 years of age;
- •breast cancer or colorectal cancer patients;
- •treated with oral Xeloda for <=5 days;
- •lack of hand-foot syndrome (palmar-plantar erythrodysesthesia).
排除标准
- •existence of clinical symptoms suggesting hand-foot syndrome;
- •use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
- •diabetes mellitus.
研究组 & 干预措施
3
干预措施: capecitabine [Xeloda] (Drug)
1
干预措施: capecitabine [Xeloda] (Drug)
1
干预措施: dexpantenol [Bepantol] (Drug)
2
干预措施: Corticosteroids (Drug)
2
干预措施: capecitabine [Xeloda] (Drug)
3
干预措施: Placebo (Drug)
结局指标
主要结局
Hand-foot syndrome onset
时间窗: Event driven
QoL C-30 score
时间窗: Weeks 7, 13 and 17
次要结局
- Adverse events(Throughout study)