Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer

NCT03730545 | Completed

• 1 other identifier: 396312366
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. The aim of this study was to assess the effect of EIN on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (SEN). The investigators believe that the proportion of cluster of differentiation 4 T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and TNF-α were lower and nutritional status was similar.

Conditions

Gastric Cancer; Enteral Immunonutrition

Keywords

gastric cancer; enteral nutrition; enteral immunonutrition; immune function; inflammation response

Outcome Measures

Primary Outcomes (3)

• Change from baseline serum level of immune cytokines to postoperative day 5

  levels of IgA, IgG and IgM in g/L,

  baseline and postoperative day 5

• Change from baseline serum level of immune markers to postoperative day 5

  count of CD4＋/CD8＋

  baseline, postoperative day 5(POD 5)

• Change from baseline serum concentration of immune markers to postoperative day 5

  percentage of CD3＋ T cell of serum

  baseline, postoperative day 5(POD 5)

Secondary Outcomes (2)

• changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers

  baseline, postoperative day 1, 3, and 5

• Change among baseline, postoperative day 3 and 5 serum nutritional markers

  baseline,postoperative day 3 and 5

Study Arms (2)

EIN group

EXPERIMENTAL

Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide.

Dietary Supplement: enteral immunonutrition

SEN group

ACTIVE COMPARATOR

Enteral formula including only basic energy components.

Dietary Supplement: enteral immunonutrition

Interventions

enteral immunonutrition DIETARY_SUPPLEMENT

Enteral nutrition was started within 12h at an infusion rate of 20ml per hour for SEN group and 16ml per hour for EIN group in the first 24h. The rates of flow were gradually increasing with 50ml/h in SEN versus 40ml/h in EIN on day 2, 70ml/h versus 56ml/h on day 3 and 100ml/h versus 80ml/h until the 7th day depending on the feeding tolerance.

EIN group; SEN group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years
• with histologically diagnosed cancer of stomach
• candidates for elective subtotal or total gastrectomy

You may not qualify if:

• pregnant or lactating woman,
• diagnoses of mental diseases
• resent severe concomitant diseases (chronic cardiopulmonary disease, chronic renal failure, etc.)
• known allergies to nutrition formula or component
• drug intolerance
• known immunodeficiency or autoimmune diseases

Sponsors & Collaborators

• West China Hospital: lead

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Eligible patients were randomly assigned in equal numbers to undergo SEN or EIN according to a computer-generated randomization list managed by a dietary nurse not involved in the study. The study was double-blind: SEN and EIN feeds were identical in color and type of container, so treatment assignments were not revealed to patients or to any staff members.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Model Details: Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 5, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 20, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11