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

Not Applicable

Completed

• Conditions: Enteral Immunonutrition; Gastric Cancer
• Interventions: Dietary Supplement: enteral immunonutrition

• Registration Number: NCT03730545
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-09-20
• Study First Submitted: 2018-10-25
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-02
• Last Update Submitted: 2018-11-02
• Study First Posted: 2018-11-05
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEN group	enteral immunonutrition	Enteral formula including only basic energy components.
EIN group	enteral immunonutrition	Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide.

Primary Outcome Measures

Name	Time	Method
Change from baseline serum level of immune cytokines to postoperative day 5	baseline and postoperative day 5	levels of IgA, IgG and IgM in g/L,
Change from baseline serum concentration of immune markers to postoperative day 5	baseline, postoperative day 5(POD 5)	percentage of CD3＋ T cell of serum
Change from baseline serum level of immune markers to postoperative day 5	baseline, postoperative day 5(POD 5)	count of CD4＋/CD8＋

Secondary Outcome Measures

Name	Time	Method
changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers	baseline, postoperative day 1, 3, and 5	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
Change among baseline, postoperative day 3 and 5 serum nutritional markers	baseline,postoperative day 3 and 5	concentration of albumin, prealbumin, and transferrin in g/L