A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Control of nausea and vomiting
研究概览
简要总结
RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and vomiting caused by opioids. It is not yet known whether aprepitant is more effective than ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.
PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of aprepitant as monotherapy for opioid-induced nausea and vomiting (OINV) in comparison to ondansetron hydrochloride in patients who have failed at least one prior anti-emetic agent/regimen.
Secondary
- To determine whether control of OINV improves quality of life.
- To determine if control in OINV decreases pain.
- To determine if control in OINV improves mood.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARM A
干预措施: aprepitant (Drug)
ARM B
干预措施: ondansetron hydrochloride (Drug)
结局指标
主要结局
Control of nausea and vomiting
时间窗: Day 1 and Day 7
次要结局
- Quality of life(Day 1 and Day 7)
- Pain control(Day 1 and Day 7)
- Mood(Day 1 and Day 7)
- Global satisfaction(Day 1 and Day 7)
研究者
Barbara Murphy, MD
Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center