EUCTR2017-002738-22-NL进行中（未招募）1 期
Double blind placebo controlled randomized intervention study to validate the beneficial effect of hydrocortisone on dexamethasone-induced neurobehavioral side effects in pediatric acute lymphoblastic leukemia
Princess Máxima Center of Pediatric Oncology0 个研究点目标入组 105 人开始时间: 2018年1月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent
- •- Age 3-18
- •- Histologically or cytologically confirmed acute lymphoblastic leukemia (ALL)
- •- Inclusion in DCOG ALL medium risk group protocol
- •- Able to comply with scheduled follow-up
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 105
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patient or parent refusal
- •- Anticipated compliance problems
- •- Underlying conditions which affect the absorption of oral medication
- •- Pregnant or lactating patients
- •- Current uncontrolled infection or any other complication which may interfere with
- •dexamethasone treatment
- •- Language barrier
- •- Pre-existing mental retardation
- •- Current oral hydrocortisone use
- •- Risperidone use
研究者
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