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

West China Hospital124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

124

Conditions

Gastric Cancer Enteral Immunonutrition

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 to 80 years * with histologically diagnosed cancer of stomach * candidates for elective subtotal or total gastrectomy Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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

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

Time frame: baseline and postoperative day 5

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

count of CD4＋/CD8＋

Time frame: 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

Time frame: baseline, postoperative day 5(POD 5)

Secondary Outcomes

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

concentration of white blood cell (WBC), C-reactive protein (CRP), interleukin-6 (IL-6) in g/L, and levels of tumor necrosis factor-α (TNF-α) in ng/L

Time frame: baseline, postoperative day 1, 3, and 5

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

concentration of albumin, prealbumin, and transferrin in g/L

Time frame: baseline,postoperative day 3 and 5