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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer：a Randomized Double Blinded Controlled Trial

Conditions
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Gastric Cancer, Enteral Immunonutrition

Intervention / Treatment
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* Dietary Supplement: enteral immunonutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIN group<br>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<br>* 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.<br>|
| Active Comparator: SEN group<br>Enteral formula including only basic energy components. | Dietary Supplement: enteral immunonutrition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | baseline,postoperative day 3 and 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, enteral nutrition, enteral immunonutrition, immune function, inflammation response