A Prospective Randomized Controlled Trial of Evonail® Solution for Prevention or Treatment of Onycholysis in Breast Cancer Patients Who Received Neoadjuvant/Adjuvant Docetaxel Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of onycholysis Gr 2 or more
研究概览
简要总结
This study is a prospective randomized controlled study of EVONAIL® solution for prevention or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study is open-labeled study. But outcome would be assessed the statistician who did not involve this study with blind data.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy
排除标准
- •Patients with breast cancer receiving palliative docetaxel chemotherapy
- •Patients having onycholysis before docetaxel treatment
研究组 & 干预措施
Experimental arm
In experimental arm, each patient painted EVONAIL® solution on nails and periungual areas once a day till developing onycholysis grade 2 or more.
干预措施: EVONAIL® solution (Drug)
Control arm
In control arm, each patient painted EVONAIL® solution on nails and periungual area twice a day after developing onycholysis grade 2.
This study design allowed cross-over. Therefore, this control arm would give EVONAIL® solution after developing onlycholysis grade 2 in spite of control arm.
干预措施: EVONAIL® solution (Drug)
结局指标
主要结局
The incidence of onycholysis Gr 2 or more
时间窗: 12weeks
次要结局
未报告次要终点
研究者
Yeon Hee Park
MD,Ph.D
Samsung Medical Center