Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence of sarcopenia 6-month after discharge
研究概览
简要总结
Gastric cancer patients after total gastrectomy will be randomized to oral nutritional supplement group or control group at discharge. Patients will receive 6 months of oral nutritional supplement or normal diet after discharge. The primary and secondary outcomes will be collected.
详细描述
Gastric cancer patients after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to oral nutritional supplement (ONS) group or control (C) group after discharge. In the ONS group, in addition to diet, and patients will also consume enteral nutritional powder (500ml/d，500kcal/d) lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.
The primary and secondary outcomes will be collected.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of patients or their legal representatives to participate in this study
- •consecutive adult (18-80 years) patients underwent radical gastrectomy (total gastrectomy)
- •nutrition Risk Screening (NRS) 2002≥3 at discharge
- •eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
- •normal liver and kidney function
排除标准
- •unable to oral or consume ONS
- •allergy to any ingredient in the oral nutrition powder
- •palliative surgery or gastric stump cancer
- •congenital acquired immune deficiency disease
- •severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications
- •motor system diseases cannot complete grip strength measurement and 5-time chair stand test
- •have cognitive impairment, unable to complete the relevant questionnaires
- •expected to require tube feeding after discharge from the hospital
研究组 & 干预措施
control
In the control group, patients will receive nutrition counseling in addition to diet.
oral nutritional supplement
In the oral nutritional supplement group, in addition to diet, and patients will also consume enteral nutrition powder (500 ml/d, 500kcal/d) lasted for 6 months after discharge.
干预措施: ONS (Other)
结局指标
主要结局
incidence of sarcopenia 6-month after discharge
时间窗: up to 6 months.
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
次要结局
- incidence of sarcopenia 1 year after discharge(up to 12 months.)
- unplanned readmission rate(up to 6 months.)
- Quality of life after discharge(up to 12 months.)
- Changes in BMI (weight and height will be combined to report BMI in kg/m^2)(up to 12 months.)
- toxicity of chemotherapy graded according to the CTCAE, version 5.0(up to 6 months.)
研究者
Wang Xinying
Prof.
Jinling Hospital, China