The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia in Hematological Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hemoglobin
研究概览
简要总结
This will be a randomised control trial designed to test the effectiveness of lactoferrin in the management of treatment-induced anemia in patients with hematological malignancies.
详细描述
Chemotherapy induced anemia (CIA) is a common adverse event in cancer patients reported to occur in 20-60% whilst the resulting low hemoglobin level is associated with impaired quality of life. Lactoferrin (LF) is a non-haem iron-binding protein that is part of the transferrin protein family, along with serum transferrin, ovotransferrin, melanotransferrin and the inhibitor of carbonic anhydrase, whose function is to transport iron in blood serum.
The aim of the study is to test the effectiveness of LF along with standard care in the management of treatment-induced anemia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on active treatment (chemotherapy i.e. cyclophosphamide, doxorubicin, rituximab, cisplatin carboplatin, etoposide)
- •Ability to independently complete the questionnaires
排除标准
- •Allergy to Milk
- •Lactose intolerance
- •Celiac disease
- •Patient of whom chemotherapy has been interrupted for more than 2 weeks (due to adverse effects)
研究组 & 干预措施
Standard treatment
Participants will receive only the standard treatment for anemia
干预措施: Recombinant human erythropoietin (Drug)
Lactoferrin
Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia
干预措施: Lactoferrin (Dietary Supplement)
Lactoferrin
Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia
干预措施: Recombinant human erythropoietin (Drug)
结局指标
主要结局
Hemoglobin
时间窗: Change from baseline at 2, 4, 6, 8, 10, 12
Concentration of Hemoglobin levels in Serum
次要结局
- Functional Assessment of Cancer Therapy Anemia(Change from baseline at 4, 8, 12 weeks)
- Ferritin(Change from baseline at 2, 4, 6, 8, 10, 12)
- LgA(Change from baseline at 2, 4, 6, 8, 10, 12 weeks)
- LgM(Change from baseline at 2, 4, 6, 8, 10, 12 weeks)
- General Quality of LIfe(Change from baseline at 4, 8, 12 weeks)
- Health related quality of life(Change from baseline at 4, 8, 12 weeks)
- Cytokine(Change from baseline at 2, 4, 6, 8, 10, 12 weeks)
- LgG(Change from baseline at 2, 4, 6, 8, 10, 12 weeks)
研究者
Dr. Andreas Charalambous
Associate Professor
Cyprus University of Technology