NCT03177317已完成不适用
A Feasibility Study of Reduced Dose of Prophylactic Dexamethasone for Elderly Patients Receiving Moderate Emetogenic Chemotherapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complete response (CR)
研究概览
简要总结
Feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in elderly patients receiving moderate emetogenic chemotherapy
详细描述
The purpose of this trial is to determine if the dose of dexamethasone used as an antiemetic drug in patients with advanced cancer could be safely reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed colorectal cancer patients with curative resection
- •ECOG performance status 0-2
- •Provision of signed, written and dated informed consent prior to any study specific procedures
- •Receiving adjuvant chemotherapy with FOLFOX (5-FU, leucovorin, oxaliplatin) regimen
排除标准
- •Having contraindication to dexamethasone
- •Having nausea or vomiting before the start of adjuvant chemotherapy
研究组 & 干预措施
Elderly patients (>= 70 years of age)
Experimental
Dexamethasone 8mg intravenously before chemotherapy
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Complete response (CR)
时间窗: 2 weeks
No emetic episode, no rescue medicine
次要结局
- Complete control (CC)(2 weeks)
- Complete protection (CP)(2 weeks)
研究者
Jin Won Kim
Associate Professor
Seoul National University Bundang Hospital
研究点 (1)
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