NCT01168505Unknown2 期
The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy
Instituto do Cancer do Estado de São Paulo2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens
研究概览
简要总结
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years
- •Patient with operated breast cancer with indication for (NEO)adjuvant therapy
- •They must have hemoglobin levels within the normal range (> 12g/dL), absence of renal and hepatic dysfunction as assessed by serum levels of urea, creatinine, AST, ALT.
- •Lack of folic acid deficiency and vitamin B12
- •Able to provide written informed consent.
排除标准
- •Use of any oral supplement containing iron;
- •Patients who have iron overload as defined by serum ferritin> 800 microg / L or transferrin saturation> 40%;
- •Patients who are pregnant or breastfeeding;
- •History of active infection or active bleeding except menstruation;
- •History of HIV or hepatitis B or C - clinically important; -
研究组 & 干预措施
iron supplement
Experimental
干预措施: ferric hydroxide saccharate (Drug)
结局指标
主要结局
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens
时间窗: 18 weeks
Anemia prevention defined by hemoglobin levels
次要结局
未报告次要终点
研究者
研究点 (2)
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