A Randomized, Phase II Study of Succinylated Gelatin for Prevention of Fluid Retention in Patients With Breast Cancer Receiving Docetaxel Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Total incidence of fluid retention
研究概览
简要总结
Breast cancer patients who received docetaxel chemotherapy were randomly divided into two groups; experimental group: the patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day; control group: observation. Primary endpoint: total incidence of fluid retention. Secondary endpoints: severity and duration of fluid retention, change in quality of life score.
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
- 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
- •Signed informed consent
- •Age ≥18 years
- •Diagnosed with breast cancer
- •Received chemotherapy with docetaxel
排除标准
- •Existed peripheral edema, ascites and pleural or pericardial effusion
- •Serum creatinine exceeds 1.5 times of the upper normal limit
- •Total serum bilirubin exceeds 1.25 times of the upper normal limit, or ASAT exceeds 2 times of the upper normal limit
研究组 & 干预措施
Succinylated gelatin
The patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day.
干预措施: Succinylated gelatin (Drug)
结局指标
主要结局
Total incidence of fluid retention
时间窗: 6 months
Total incidence of peripheral edema, ascites and pleural or pericardial effusion of patients during the period of docetaxel chemotherapy
次要结局
- change in Functional Assessment of Cancer Therapy-Breast subscale score(6 months)
- severity of fluid retention(6 months)
研究者
Kun Wang
Professor
Guangdong Provincial People's Hospital