Effects of Parenteral Nutrition in Hematopoietic Stem Cell Transplantation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0
研究概览
简要总结
Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral nutrition are becoming more strict. The study aims to identify the role of parenteral nutrition in the context of rapidly changing supportive care approaches in HSCT
详细描述
The study is interventional: in children and adolescents (2-17 years), adults with blood malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional status, parenteral nutrition tolerability and effectiveness will be assessed before and one month after HSCT. All patients who require parenteral nutrition will pass randomization via envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid emulsions. The results will be compared with a control group which will not receive additional nutritional support. The methods used for measurement of nutritional status are: weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests, diet amount record.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autologous HSCT
- •Allogeneic HSCT
- •Patients with indications for parenteral nutrition defined as unable to eat more than 50% of oral food intake due to posttransplant complications which leads to malnutrition and malabsorption
- •Signed informed consent
- •Age > 2 years
排除标准
- •Secondary HSCT
研究组 & 干预措施
Glucose/Amino acids
Patients who will require nutritional support will receive parenteral nutrition consisting of glucose and amino acids according age and weight
干预措施: Glucose/Amino acids (Drug)
Glucose/Amino acids/Lipids
Patients who will require nutritional support will receive parenteral nutrition consisting of glucose, amino acids and lipid emulsions according age and weight
干预措施: Glucose/Amino acids/Lipids (Drug)
结局指标
主要结局
Number of patients with low tolerability of different parenteral nutrition schemes in HSCT According CTCAE ver. 5.0
时间窗: 60 days
Gastrointestinal toxicity symptoms (anorexia, vomiting, nausea, mucositis, diarrhea) before, during and after discontinuation of parenteral nutrition
次要结局
- Changes in body mass index in HSCT depending on nutritional support approach(30 days)
- Impact of parenteral nutrition on infection episodes after HSCT(60 days)
- Severity and duration of anorexia, nausea, vomiting prevention(60 days)
- Changes in body weight in HSCT depending on nutritional support approach(30 days)
- Changes in body composition in HSCT depending on nutritional support approach(30 days)
- Changes in resting energy expenditure in HSCT depending on nutritional support approach(30 days)
研究者
Ivan S Moiseev
Deputy Director for research, Raisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation
St. Petersburg State Pavlov Medical University