Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of area of psoas muscle
研究概览
简要总结
Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including the physical activity, weight loss, and nutritional profiles, will be evaluated among these patients.
详细描述
This will be a double-blind, randomized, and placebo-controlled study. At least 80 evaluable patients who are scheduled for gastrectomy for gastric adenocarcinoma cancer will be randomly assigned to the control or treatment group. Each group will have at least 40 patients. The CT scan will be evaluated before surgery and on postoperative day (POD) 90. Moreover, the patient will wear the smart watch to record daily walking steps. Laboratory data will be check before gastrectomy and on POD 90.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult gastric cancer receiving gastrectomy
排除标准
- •Hepatic insufficiency
- •Renal insufficiency
- •can not tolerate oral or enteral feeding 7 days after gastrectomy
- •can not receive computed tomograph
- •can not waer the wearable devices
结局指标
主要结局
Change of area of psoas muscle
时间窗: 84 days after gastrectomy
area od psoas muscle on the CT scan
次要结局
- Walking steps(28,56, and 84 days after gastrectomy)
- body weight(84 days after gastrectomy)
- Change of serum albumin value(84 days after gastrectomy)
- Change in white blood cells counts(84 days after gastrectomy)
- Change in lymphocyte cells counts(84 days after gastrectomy)
- Change of serum pre-albumin value(84 days after gastrectomy)
研究者
National Taiwan University Clinical Trial Center
Jin-Ming Wu, Clinical Associate Professor & PhD
National Taiwan University Hospital