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

Gastric Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730545
• Other study ID #: 396312366
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: September 20, 2018

Study information

• Verified date: November 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 20, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enteral Immunonutrition
• Gastric Cancer
• Stomach Neoplasms

Intervention

Dietary Supplement:
• enteral immunonutrition
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline serum level of immune markers to postoperative day 5	count of CD4+/CD8+	baseline, postoperative day 5(POD 5)
Primary	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	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-a (TNF-a) in ng/L	baseline, postoperative day 1, 3, and 5
Secondary	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