Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Red blood cell (RBC) transfusion rate
研究概览
简要总结
Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?
详细描述
Anemia is a common condition during chemotherapy administration. Treatment options usually include oral iron supplementation and blood transfusion. However, oral iron has gastrointestinal side effects, which affects patient compliance, and only a small amount of oral iron can be absorbed from the gastrointestinal tract. Intravenous iron may overcome a block of iron absorption and iron recycling induced by hepcidin. Therefore, it may increase hemoglobin level and reduced blood transfusion in cancer patients receiving chemotherapy.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20-70 years
- •Good performance status (Zubrod score < 2)
- •No serious underlying disease
- •Normal renal function test
- •Normal liver function test
- •Platinum based chemotherapy is the first line regimen
- •No prior or receiving radiotherapy
排除标准
- •Iron hypersensitivity
- •Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
- •Progressive disease
- •Bone marrow metastasis
研究组 & 干预措施
Intravenous iron
Iron sucrose 200 mg intravenous infusion in 15 minutes
干预措施: Intravenous iron (Drug)
Oral iron
Ferrous fumarate 200 mg oral three times a day
干预措施: Intravenous iron (Drug)
结局指标
主要结局
Red blood cell (RBC) transfusion rate
时间窗: 6 months
The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.
次要结局
- Number of participants with adverse events(6 months)
- total number of red blood transfusion units and number of cycles requiring blood transfusion(6 months)
研究者
Tarinee Manchana
Department of Obstetrics and Gynecology
Chulalongkorn University