CTRI/2022/06/043104尚未招募不适用
Prevalence of iron deficiency anemia in cancer patient andtherapeutic outcomes
Dr Malini Mohan1 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2022年6月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Prevalence of patients with absolute and functional iron deficiency anemia
研究概览
简要总结
This is a prospective observational study in which we aim to assess the burden of iron deficiency anemia in cancer patients visiting Kasturba Medical College, Manipal. Those patients detected to have iron deficiency anemia will be given iron supplementation and we will assess the efficacy of the same.Use of intravenous iron for treatment has effectively helped in reducing the need for frequent blood transfusions. It also has better tolerability profile compared to oral iron.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Hemoglobin level less than or equal to 10 g/dL.
- •Transferrin saturation < 20 %.
- •Any stage solid malignancies.
排除标准
- •Age less than 18yrs.
- •Pregnant women.
- •any evidence of hemolysis.
- •Active gastrointestinal bleeding (stool occult blood positive).
- •active infection requiring systemic antibiotics.
- •HIV infection.
- •active Tuberculosis infection.
- •liver/ renal dysfunction.
- •Grade 2 or higher based on National Cancer Institute Common Toxicity Criteria: Bilirubin >1.5 times normal, Transaminases >2.5 times normal), renal dysfunction (serum creatinine levels > or equal to 2.0 mg/dL).
- •Malignant Bone marrow infiltration -Received iron supplementation / blood transfusion in the preceding 4 weeks.
结局指标
主要结局
Prevalence of patients with absolute and functional iron deficiency anemia
时间窗: 2 years
次要结局
- a)Best response to treatment - Response will be defined as proportion of patients achieving an increase in hemoglobin at any time from baseline to end of 12 weeks. Response criteria is defined as follows: -(Complete response : increase in Hemoglobin level 2.0 g/dL above baseline, and/ or transfusion free.)
研究者
研究点 (1)
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