Skip to main content
OpenTrials
Completed

NCT Number: NCT03730545

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Enteral Immunonutrition Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: baseline and postoperative day 5

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

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

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

    count of CD4＋/CD8＋

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

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

    percentage of CD3＋ T cell of serum

Secondary outcomes

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

    Time frame: 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

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

    Time frame: baseline,postoperative day 3 and 5

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

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2018
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.