The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- GI associated adverse events
研究概览
简要总结
Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
详细描述
Primary Objective:
Use both listed and relatively safe drug, Silymarin, to improve the intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
Patient Selection and Enrollment:
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total.
Plan of the Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient who is between 20 to 80 years old
- •The patient who is diagnosed metastatic colorectal cancer and received chemotherapy with FOLFIRI regimen
- •The female patient should not be pregnant or breast-feeding
- •The patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease.
- •The patient who has no associated drug allergy to this trial.
- •The patient who is in compliance with prescribed medication.
- •The patient who is willing to sign the permit of the clinical trial.
排除标准
- •The patients who do not meet the main inclusion criteria or are not willing to sign the permit.
- •The patient who has viral hepatitis or carrier with impaired liver function.
研究组 & 干预措施
prescription of silymarin
During six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150mg) three times daily from day 1 to day 7 during one cycle of treatment.
干预措施: Silymarin (Drug)
结局指标
主要结局
GI associated adverse events
时间窗: 3 months
Response rate and grades of GI associated adverse events (AEs) according to the Response Evaluation Criteria in Solid Tumors (version 1.1)
次要结局
未报告次要终点
研究者
Jaw-Yuan Wang, MD, PhD
Professor
Kaohsiung Medical University Chung-Ho Memorial Hospital