Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer

NCT03123432 | Completed

• 1 other identifier: KMUHIRB-2011-05-01(II)
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

immunomodulating nutrients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

Study Arms (2)

immunomodulating nutrients enriched diet

EXPERIMENTAL

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

standard diet

ACTIVE COMPARATOR

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

Interventions

immunomodulating nutrients enriched diet DIETARY_SUPPLEMENT

Also known as: neo-mune

immunomodulating nutrients enriched diet

standard diet DIETARY_SUPPLEMENT

standard diet

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jaw-Yuan Wang, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Superintendent

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 21, 2017
• Study Start: June 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)