ISRCTN11830961已完成不适用
Randomised controlled study of iron supplementation to support the response to recombinant human erythropoietin for the treatment of chemotherapy-induced anaemia
Barts and the London NHS Trust (UK)0 个研究点目标入组 80 人开始时间: 2007年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Any patients with a haemoglobin of less than or equal to 10.5 g/dl who is going to receive at least six more weeks of chemotherapy for any non-myeloid malignancy
- •2. Any patients with a percent saturation of transferrin more than or equal to 20% and a serum ferritin between 225 and 2250 pmol/L. Confirmatory data will include a reticulocyte haemoglobin content (CHR) more than 31 and zinc protoporphyrin (ZPP) less than 80
- •3. Patients must be able to understand and signed written informed consent
- •4. An Eastern Cooperative Oncology Group (ECOG) performance status of zero to two
排除标准
- •1. Patients with an anaemia of origin other than cancer or cancer chemotherapy
- •2. Prior intravenous (IV) iron therapy
- •3. Expectation of actual transfusion requirement during the course of the study. A transfusion given after randomisation wil be a study endpoint for that patient.
- •4. Allergy or intolerance to recombinant erythropoietin
- •5. Uncontrolled hypertension
- •6. Active infection
- •7. Primary bone marrow malignancies except for multiple myeloma, chronic lymphocytic leukaemia and indolent non Hogkin's lymphoma, where erythropoiesis-stimulating agents (ESA) therapy has been proven to be beneficial
研究者
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