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

Primary Purpose

Gastric Cancer, Enteral Immunonutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
enteral immunonutrition
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring gastric cancer, enteral nutrition, enteral immunonutrition, immune function, inflammation response

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    EIN group

    SEN group

    Arm Description

    Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide.

    Enteral formula including only basic energy components.

    Outcomes

    Primary Outcome Measures

    Change from baseline serum level of immune cytokines to postoperative day 5
    levels of IgA, IgG and IgM in g/L,
    Change from baseline serum level of immune markers to postoperative day 5
    count of CD4＋/CD8＋
    Change from baseline serum concentration of immune markers to postoperative day 5
    percentage of CD3＋ T cell of serum

    Secondary Outcome Measures

    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
    Change among baseline, postoperative day 3 and 5 serum nutritional markers
    concentration of albumin, prealbumin, and transferrin in g/L

    Full Information

    First Posted
    October 25, 2018
    Last Updated
    November 2, 2018
    Sponsor
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03730545
    Brief Title
    Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    July 1, 2018 (Actual)
    Study Completion Date
    September 20, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Enteral Immunonutrition
    Keywords
    gastric cancer, enteral nutrition, enteral immunonutrition, immune function, inflammation response

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
    Masking
    ParticipantInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    124 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EIN group
    Arm Type
    Experimental
    Arm Description
    Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide.
    Arm Title
    SEN group
    Arm Type
    Active Comparator
    Arm Description
    Enteral formula including only basic energy components.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    enteral immunonutrition
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change from baseline serum level of immune cytokines to postoperative day 5
    Description
    levels of IgA, IgG and IgM in g/L,
    Time Frame
    baseline and postoperative day 5
    Title
    Change from baseline serum level of immune markers to postoperative day 5
    Description
    count of CD4＋/CD8＋
    Time Frame
    baseline, postoperative day 5(POD 5)
    Title
    Change from baseline serum concentration of immune markers to postoperative day 5
    Description
    percentage of CD3＋ T cell of serum
    Time Frame
    baseline, postoperative day 5(POD 5)
    Secondary Outcome Measure Information:
    Title
    changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers
    Description
    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
    Time Frame
    baseline, postoperative day 1, 3, and 5
    Title
    Change among baseline, postoperative day 3 and 5 serum nutritional markers
    Description
    concentration of albumin, prealbumin, and transferrin in g/L
    Time Frame
    baseline,postoperative day 3 and 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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

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