NCT01974024已完成3 期
Antiemetic Corticosteroid Rotation From Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated With Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- The intensities of hiccups
研究概览
简要总结
The aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of DIH.
详细描述
we planned a randomized prospective trial for cancer patients with DIH. The objective of the present study was to determine whether the rotation of corticosteroids affects the incidence and intensity of DIH without compromising the antiemetic efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •all solid cancer patients on chemotherapy
- •age >18 years
- •received dexamethasone as an antiemetic
排除标准
- •brain metastases
- •hiccups before dexamethasone administration
- •uncontrolled diabetes mellitus
- •uncontrolled esophagitis or peptic ulcer
研究组 & 干预措施
Methylprednisolone
Experimental
Dexamethasone was replaced with methylprednisolone as an antiemetic.
干预措施: methylprednisolone (Drug)
Dexamethasone
Active Comparator
Dexamethasone was re-administered in the cycle.
干预措施: methylprednisolone (Drug)
结局指标
主要结局
The intensities of hiccups
时间窗: 2 months
Clinically assessed every cycles(2-4weeks). The intensities of hiccups were assessed using a NRS.
次要结局
- The intensities of emesis(2 months)
研究者
In Gyu Hwang
In Gyu Hwang/Associate Professor
Chung-Ang University
研究点 (2)
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