The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 696
- 试验地点
- 1
- 主要终点
- 3-year disease free survival after discharge
研究概览
简要总结
Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.
详细描述
Gastric cancer patients with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil 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 —（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 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
- •nutrition Risk Screening (NRS) 2002≥3 at discharge
- •eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
排除标准
- •unable to oral or consume ONS
- •has received neoadjuvant chemotherapy
- •palliative surgery or gastric stump cancer or Borrmann type IV
- •oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
- •serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension
- •severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia
- •diabetes has developed complications or uncontrolled by medications
- •previous use of drugs affecting immune function
- •previous use of fish oil capsule > 2 times / week or contraindications to fish oil capsule
- •motor system diseases cannot complete grip strength measurement and 5-time chair stand test
结局指标
主要结局
3-year disease free survival after discharge
时间窗: up to 3 years
from date of randomization to disease recurrence or death
次要结局
- Changes in weight(up to 12 months.)
- 3-year overall survival(up to 3 years.)
- unplanned readmission rate(up to 6 months.)
- Quality of life after discharge(up to 12 months.)
- incidence of sarcopenia 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.)
- Changes in prealbumin level(up to 12 months.)
- Changes in hemoglobin level(up to 12 months.)
- toxicity of chemotherapy graded according to the CTCAE, version 5.0(up to 6 months.)
- Changes in albumin level(up to 12 months.)
研究者
Wang Xinying
Prof.
Jinling Hospital, China