Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
研究概览
简要总结
In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two groups: intervention and control with balanced block randomization method. Intervention group received Zinc sulfate immediately after start conditioning regimen and continued for two weeks. Control group received placebo at the same manner. Prevalence and severity of mucositis will be compared in two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing bone marrow transplantation
- •Signed informed consent
排除标准
- •Unable take drug (or placebo) orally
研究组 & 干预措施
Intervention
Received Zinc Sulfate
干预措施: Zinc Sulfate (Drug)
Control
Control group
干预措施: Placebo (Drug)
结局指标
主要结局
The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation
时间窗: 1 year
次要结局
- Evaluation of Zinc Sulfate concentration(1 year)
- Evaluation of Zinc Sulfate advance effects(1 year)