immunomodulating nutrients in perioperative patients with gastric cancer

Conditions: Gastric Cancer

Summary: 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.

primary objective: 1. 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. number of subjects: eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each. plan of the study: 1. this is a randomized, comparative, double blinded study in 2 arms. 2. study schedule study date: the time getting approval letter issued by both regulatory authority and institutional review board (irb). duration of the study: 5 years. 3. duration of treatment: treatment was administered before curative surgery for gastric adenocarcinoma or gastric gist, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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

Keywords: immunomodulating nutrients