Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

Kaohsiung Medical University Chung-Ho Memorial Hospital34 enrolled

Overview

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or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastric Cancer

Interventions

immunomodulating nutrients enriched dietDIETARY_SUPPLEMENT

standard dietDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

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.