Randomized, Placebo-controlled Trial of Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis in Patients Receiving High Dose Cisplatin in Routine Medical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Number of Patients Who Had Complete Response
研究概览
简要总结
The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.
详细描述
Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.
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
- Triple (Participant, Care Provider, 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
- •schedule to receive first cycle of cisplatin > 50 mg/m^2
- •pathologically or histologically confirmed solid cancer
- •more than 18 years old
- •creatinine clearance more than 50 ml/min
- •aminotransferase less than 2 times of upper normal limit
排除标准
- •pregnant woman
- •patients with episode of vomiting within 24 hours prior to chemotherapy session
- •gut obstruction
- •brain metastasis
- •abdominal or pelvic irradiation
- •no history of allergy to study drugs
研究组 & 干预措施
metoclopramide
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
干预措施: metoclopramide (Drug)
placebo
ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5
干预措施: placebo (Drug)
结局指标
主要结局
Number of Patients Who Had Complete Response
时间窗: 5 days after receiving chemotherapy
number of patients who experience no emesis and need no rescue treatment in 5-day period
次要结局
- Toxicities and Severity of Nausea and Vomiting(5 days after receiving chemotherapy)