A RANDOMIZED CONTROLLED MULTICENTER NON-INFERIORITY TRIAL OF TWICE DAILY LOW DOSE DEXAMETHASONE VERSUS USUAL DOSE DEXAMETHASONE FOR SYMPTOM CONTROL IN CHILDREN WITH A BRAIN TUMOUR UNDERGOING CRANIAL OR CRANIOSPINAL RADIATION
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Effectiveness of dexamethasone on vomiting
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.
详细描述
Dexamethasone is an effective medication to ameliorate radiation induced headache and vomiting. In our Toronto experience dexamethasone in low doses (1 mg/m2/day) is sufficient in treating these symptoms. However this experience is not shared from many neuro-oncology centers of excellence that more commonly use 5 mg/m2/day according to the results of the trans-Canadian survey. A prospective multicenter trial evaluating the effectiveness of dexamethasone in different dose regimens in symptomatic children while undergoing CNS radiation will elucidate the appropriate dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, 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
Standard Arm
Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience.
If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms.
干预措施: High dose dexamethasone (Drug)
Control Arm
Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience.
If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms.
干预措施: Low dose dexamethasone (Drug)
结局指标
主要结局
Effectiveness of dexamethasone on vomiting
时间窗: 24-48 hours after first dose of dexamethasone
The primary outcome will be the evaluation of effectiveness of dexamethasone on vomiting after 24-48 hours (after 2-4 doses of treatment). Vomiting is defined as either retching or vomiting and will be counted in events. The frequency of emetic episodes/day will be documented in the daily diary. The effectiveness of dexamethasone will be counted in number of episodes and evaluated on day 2 (48 hours after first dose).
次要结局
- Headaches(0-48 hours after first dose of dexamethasone)
- Adverse events and side effects(Duration of participation in study)
- Quality of life(Baseline and at end of participation in study)
研究者
Ute Bartels
Staff Physician
The Hospital for Sick Children