NCT00064272已完成2 期
Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Most efficacious dose
研究概览
简要总结
RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.
详细描述
OBJECTIVES:
Primary
- Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.
Secondary
- Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
- Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years（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 I
Experimental
Patients receive lower-dose oral ginger twice daily.
干预措施: ginger extract (Drug)
Arm II
Experimental
Patients receive higher-dose oral ginger twice daily.
干预措施: ginger extract (Drug)
Arm III
Placebo Comparator
Patients receive oral placebo twice daily.
干预措施: placebo (Other)
结局指标
主要结局
Most efficacious dose
Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)
Safety
次要结局
未报告次要终点
研究者
研究点 (6)
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