Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- immunomodulating effects
研究概览
简要总结
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
详细描述
Primary Objective:
- The primary end points:
To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α). 2. Secondary Objectives:
(1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count.
(2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-85 years old
- •Histologically proven primary gastric cancer or GIST.
- •Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc.
- •Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.
排除标准
- •They were less than 20 years or over 85 years old
- •Hepatic dysfunction or bile stasis (serum total bilirubin >2.5 mg/dL)
- •Renal dysfunction (serum creatinine >1.5 mg/dL), or required hemodialysis
- •Cardiac dysfunction (NYHA functional class >III, or stroke history)
- •Severe hypoalbuminemia (albumin <2.5 g/dL)
- •Karnofsky performance status less than 60
- •Overweight (body mass index [BMI] >30 kg/m2)
- •Exhibited drug abuse or chronic alcoholism
- •Had life-threatening disease, or underwent emergent surgery
- •With infection or bowel obstruction
- •Pregnant or lactating
- •Had received chemotherapy within 14 days of the initiation of the trial
- •Had received immunosuppressive therapy or had immunological diseases recently
- •Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study
- •Hypersensitive to casein, fish oil, soybean, or corn oil
结局指标
主要结局
immunomodulating effects
时间窗: at discharge from the hospital or 14 days after surgery, whichever occurred first
Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.
次要结局
- blood triglycerides (TG) in mg/dL(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood cholesterol in mg/mL(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood high-density lipoprotein (HDL) in mg/mL(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood alanine aminotransferase (ALT) in U/L(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- length of hospital stay after surgery(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood sodium (Na) mEq/L(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood leukocyte count cells/μL(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood albumin in g/dL(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood prealbumin in mg/dL(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood aspartate aminotransferase (AST) in U/L(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- postoperative complications(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- body mass index (BMI) in kg/m^2(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood glucose(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood urine nitrogen(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- blood low-density lipoprotein (LDL) in mg/mL(at discharge from the hospital or 14 days after surgery, whichever occurred first)
- time to first bowel action(at discharge from the hospital or 14 days after surgery, whichever occurred first)
研究者
Jaw-Yuan Wang, MD, PhD
Professor, Vice Superintendent
Kaohsiung Medical University Chung-Ho Memorial Hospital