Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 18
- 主要终点
- Rise or normalization of hemoglobin
研究概览
简要总结
Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. In clinical practice iron substitution is usually administered orally. Due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. In the framework of a randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in both treatment arms for effect comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Metastatic or inoperable colorectal carcinoma. No curative therapy available.
- •Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study.
- •Iron deficiency anemia: hemoglobin ≤ 10.5 g/dl and transferrin saturation < 20 % and/or serum ferritin < 20 ng/ml
- •Male and female patients aged ≥ 18 years; maturity
- •Written informed consent
- •Life expectancy > 6 months
- •Body weight ≥ 40 kg
排除标准
- •Oral or intravenous iron substitution within the last 4 weeks
- •Age < 18 years or body weight < 40 kg
- •Absorption dysfunction due to short bowel syndrome or after gastric resection
- •Therapy with recombinant erythropoietin within the last 4 weeks
- •Chronic diarrhea
- •Chronic inflammatory bowel disease
- •Ferritin > 800 mg/dl at baseline
- •Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex
- •Known vitamin B12 or folic acid anemia
- •Necessary total parenteral nutrition
- •Participation in another interventional study
- •Pregnancy or lactation
研究组 & 干预措施
FERRIC CARBOXYMALTOSE
max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
干预措施: FerInject (Drug)
ferro sanol(R) duodenal 100 mg
200 mg ferro sanol per day over 12 weeks
干预措施: Ferro sanol (Drug)
结局指标
主要结局
Rise or normalization of hemoglobin
时间窗: 12 weeks
次要结局
- Fatigue as measured by EORTC-QLQ-FA13(12 weeks)
- Quality of life as measured by EORTC-C30(12 weeks)
- Handgrip strength as measured by Hydraulic Hand Dynamometer(12 weeks)
- Number of allogenic blood transfusions (in total and per patient)(12 weeks)
- Time until rise or normalisation of hemoglobin(12 weeks)
- Genesis of the iron deficiency anemia(12 weeks)
- Number of therapy with recombinant erythropoietin(12 weeks)
- Dose of therapy with recombinant erythropoietin(12 weeks)
- Duration of therapy with recombinant erythropoietin(12 weeks)
- Inflammatory parameters(12 weeks)
- Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)(12 weeks)
- Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)(12 weeks)
- Tolerance(12 weeks)
- Incidence and severity of adverse events(12 weeks)
- Dropout rate due to toxicity or patient will(12 weeks)
- Overall survival(12 weeks)