Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer：a Randomized Double Blinded Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- West China Hospital
- Enrollment
- 124
- Primary Endpoint
- Change from baseline serum level of immune cytokines to postoperative day 5
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
EIN group
Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide.
Intervention: enteral immunonutrition (Dietary Supplement)
SEN group
Enteral formula including only basic energy components.
Intervention: enteral immunonutrition (Dietary Supplement)
Outcomes
Primary Outcomes
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,
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
Change from baseline serum level of immune markers to postoperative day 5
Time Frame: baseline, postoperative day 5(POD 5)
count of CD4＋/CD8＋
Secondary Outcomes
- changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers(baseline, postoperative day 1, 3, and 5)
- Change among baseline, postoperative day 3 and 5 serum nutritional markers(baseline,postoperative day 3 and 5)
Investigators
Yong Zhou
associate chief physician
West China Hospital