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Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

immunomodulating nutrients enriched diet

standard diet

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring immunomodulating nutrients

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

immunomodulating nutrients enriched diet

standard diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

blood glucose

blood urine nitrogen

blood aspartate aminotransferase (AST) in U/L

blood alanine aminotransferase (ALT) in U/L

blood triglycerides (TG) in mg/dL

blood cholesterol in mg/mL

blood low-density lipoprotein (LDL) in mg/mL

blood high-density lipoprotein (HDL) in mg/mL

blood sodium (Na) mEq/L

blood leukocyte count cells/μL

blood albumin in g/dL

blood prealbumin in mg/dL

body mass index (BMI) in kg/m^2

postoperative complications

postoperative complications that related to surgery

time to first bowel action

interval of surgery to first bowel action (hours)

length of hospital stay after surgery

length of hospital stay after surgery (days)

Full Information

NCT ID

NCT03123432

First Posted

April 5, 2017

Last Updated

April 20, 2017

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03123432

Brief Title

Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

June 1, 2011 (Actual)

Primary Completion Date

June 1, 2016 (Actual)

Study Completion Date

September 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

immunomodulating nutrients

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

immunomodulating nutrients enriched diet

Arm Type

Experimental

Arm Description

Arm Title

standard diet

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

immunomodulating nutrients enriched diet

Other Intervention Name(s)

neo-mune

Intervention Type

Dietary Supplement

Intervention Name(s)

standard diet

Primary Outcome Measure Information:

Title

immunomodulating effects

Description

Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.

Time Frame