A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
研究概览
简要总结
Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients.
This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •metastatic colon cancer patients
- •male or female
- •treated EGFRI
排除标准
- •prior treatment with EGFRI
研究组 & 干预措施
RECONVAL CREAM
half face treated with RECONVAL CREAM
干预措施: RECONVAL CREAM (Drug)
PLACEBO
half face treated with PLACEBO cream
干预措施: PLACEBO (Drug)
结局指标
主要结局
Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
时间窗: 12 weeks
Reduction in numbers of papulo-pustular eruptions in the treatment fields compared to the placebo treated side. Changes in follicular eruptions, dryness/redness of skin estimated by the grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) skin toxicity study group 4.0. Patients own experience of efficacy estimated by questionnaire.
次要结局
未报告次要终点