NCT00892502已完成不适用
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy? A Clinical, Prospective, Randomized, Blinded Examination of Patients Suffering From Hematological Malignancies Treated With Intensive Chemotherapy and/or Radiotherapy.
Copenhagen University Hospital at Herlev1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年5月最近更新:
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
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
研究概览
简要总结
The purpose of this study is to determine whether treatment with Bismuth can reduce the toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 18 years or over referred to the Department of Haematology L, Herlev Hospital, with a view to 'cytostatic'? treatment of or radiotherapy for haematological malignancy
排除标准
- •Pregnant women and nursing mothers
- •No informed consent from patient
- •Known hyper sensitivity to bismuth or other tablet content
- •Severe renal insufficiency with creatinin clearance below 25 ml/min.
- •Patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth)
- •Other experimental treatment within past four weeks.
研究组 & 干预措施
1
Active Comparator
Bismuth tablets
干预措施: Bismuth tablets (Drug)
2
Placebo Comparator
Placebo tablets, containing no active substance
干预措施: Placebo tablets (Drug)
结局指标
主要结局
To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy
时间窗: daily during treatment
次要结局
- To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively(6 months)
研究者
研究点 (1)
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