Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

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)

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Dietary supplement: immunomodulating nutrients enriched diet; Dietary supplement: standard diet

Detailed Description

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or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.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
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immunomodulating nutrients enriched diet; 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; Other Names: neo-mune
Active Comparator: standard diet; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Chair: Jaw-Yuan Wang, PhD, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: immunomodulating nutrients
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: KMUHIRB-2011-05-01(II)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No