Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

NCT ID: NCT03123432

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-01
• Study Completion Date: 2016-09-01

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:

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to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

immunomodulating nutrients enriched diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: ACTIVE_COMPARATOR

standard diet

Intervention Type: DIETARY_SUPPLEMENT

Interventions

immunomodulating nutrients enriched diet

Intervention Type: DIETARY_SUPPLEMENT

standard diet

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

neo-mune

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jaw-Yuan Wang, MD, PhD

Professor, Vice Superintendent

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaw-Yuan Wang, PhD

Role: STUDY_CHAIR

Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

Locations

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-2011-05-01(II)

Identifier Type: -

Identifier Source: org_study_id