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

Sichuan University

Status: Completed

Conditions: Gastric Cancer; Enteral Immunonutrition

Treatments: Dietary Supplement: enteral immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03730545

396312366

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

EIN group

Experimental group

Description:

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

Treatment:

Dietary Supplement: enteral immunonutrition

SEN group

Active Comparator group

Description:

Enteral formula including only basic energy components.

Treatment:

Dietary Supplement: enteral immunonutrition