Enteral Immunonutrition, Gastric Cancer
Conditions
Keywords
gastric cancer, enteral nutrition, enteral immunonutrition, immune function, inflammation response
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.
Interventions
DIETARY_SUPPLEMENTenteral 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.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Eligible patients were randomly assigned in equal numbers to undergo SEN or EIN according to a computer-generated randomization list managed by a dietary nurse not involved in the study. The study was double-blind: SEN and EIN feeds were identical in color and type of container, so treatment assignments were not revealed to patients or to any staff members.
Intervention model description
Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 level of immune markers to postoperative day 5 | baseline, postoperative day 5(POD 5) | count of CD4＋/CD8＋ |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed