Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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). 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: This is a randomized, comparative, double blinded study in 2 arms. 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. 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or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.

Official Title
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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)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Dietary Supplement: immunomodulating nutrients enriched diet
* Dietary Supplement: standard diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immunomodulating nutrients enriched diet<br>Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. | Dietary Supplement: immunomodulating nutrients enriched diet<br> <br> * Other names: neo-mune;|
| Active Comparator: standard diet<br>Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. | Dietary Supplement: standard diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunomodulating effects | Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes. | at discharge from the hospital or 14 days after surgery, whichever occurred first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 aspartate aminotransferase (AST) in U/L |  | 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 | 
| 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 low-density lipoprotein (LDL) 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 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 | 
| body mass index (BMI) in kg/m^2 |  | at discharge from the hospital or 14 days after surgery, whichever occurred first | 
| postoperative complications | postoperative complications that related to surgery | at discharge from the hospital or 14 days after surgery, whichever occurred first | 
| time to first bowel action | interval of surgery to first bowel action (hours) | at discharge from the hospital or 14 days after surgery, whichever occurred first | 
| length of hospital stay after surgery | length of hospital stay after surgery (days) | at discharge from the hospital or 14 days after surgery, whichever occurred first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunomodulating nutrients