NCT00828399已完成4 期
Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Castilla-León Health Service2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of patients with acute radiation enteritis
研究概览
简要总结
Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with antioxidant effects that can protect tissues of damage dued to radiation. The investigators designed a randomized, double-blind trial phase III to study if glutamine prevents acute radiation enteritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 yr
- •Gynaecological,prostatic, rectal or other abdominal cancer
- •Radiotherapy with/without chemotherapy
排除标准
- •life expectancy < 1 yr
- •Age < 18 yr
- •gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
- •moderate to severe chronic renal failure
- •hepatic cirrhosis
结局指标
主要结局
Number of patients with acute radiation enteritis
时间窗: 2 months
RTOG criteria
次要结局
- Reduction in inflammatory markers and oxydative stress(2 months)
研究者
研究点 (2)
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