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Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients (PAOPUFAGC)

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
omega-3 polyunsaturated fatty acids
Sponsored by
Jian Suo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring omega-3 gastric cancer perioperation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients coming to FirstJilinU diagnosed gastric cancer by endoscopy and pathology.
  • No preoperative treatment, the gastric cancer radical surgery in our hospital is the first treatment.
  • Nutrition screening score (NRS 3 or higher).
  • Albumin and (or) immune enhancer were not used within two weeks before operation .
  • No blood system diseases.

Exclusion Criteria:

  • Being in the acute phase of inflammation before operation and emergency surgery.
  • Patients combined metabolic diseases such as diabetes, hyperthyroidism, immune system disease or taking immunosuppressants;
  • Combined hepatic insufficiency.
  • Spleen resected in operation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    omega-3 polyunsaturated fatty acids

    Arm Description

    The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg.

    Outcomes

    Primary Outcome Measures

    blood immune factors

    Secondary Outcome Measures

    Full Information

    First Posted
    July 23, 2013
    Last Updated
    July 26, 2013
    Sponsor
    Jian Suo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01910948
    Brief Title
    Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients
    Acronym
    PAOPUFAGC
    Official Title
    Efficacy of Perioperative Application of Omega-3 Polyunsaturated Fatty Acids on Postoperative Immunization in Gastric Cancer Patients - A Prospective, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    March 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jian Suo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement of nutritional status, incidence rate of related complications, and whether it can reduce the average postoperative hospitalization days.
    Detailed Description
    Methods: Choose from 6 to 2013-2013-12 gastric cancer patients, according to inclusion criteriaS to choose the objectS of study from the gastric cancer patients coming to our hospital 2013-06 to 2013-12 .The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg. Detect and compare CRP、TNF-α、IL-1、IL-4、lL-6、 IL-8、lL-10 levels of two groups in days before parenteral nutrition and applicating 3rd day and postoperative 1st, 3rd, 5th,and detect liver function in preoperative and postoperative 2nd,5th,7th day. Record postoperative anal exhaust time, postoperative complications, postoperative hospital days, preoperative and postoperative body weight.Results: Trail group patients compared with the control group,Omega-3 Polyunsaturated Fatty Acids can reduce early postoperative inflammatory cytokines release, reduce the postoperative fever time, reduce the incidence of systemic inflammatory response syndrome, promote the recovery of gastrointestinal function, improve the nutritional state of patients, reduce infection and related complications after the surgery and reduce postoperative hospitalization days. Conclusions: Perioperative application of omega 3 PUFA can reduce the release of inflammatory cytokines, regulating cell and humoral immunity, reduce the postoperative fever time, reduce the local inflammation medium that inhibit the gastrointestinal peristalsis, promote the recovery of gastrointestinal function, improve the nutritional state of patients, thereby reducing the occurrence of postoperative infection and related complications, reduce postoperative hospitalization days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    omega-3 gastric cancer perioperation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    omega-3 polyunsaturated fatty acids
    Arm Type
    Experimental
    Arm Description
    The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg.
    Intervention Type
    Drug
    Intervention Name(s)
    omega-3 polyunsaturated fatty acids
    Other Intervention Name(s)
    omega-3 PUFA, ω-3 PUFA
    Intervention Description
    The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg.
    Primary Outcome Measure Information:
    Title
    blood immune factors
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients coming to FirstJilinU diagnosed gastric cancer by endoscopy and pathology. No preoperative treatment, the gastric cancer radical surgery in our hospital is the first treatment. Nutrition screening score (NRS 3 or higher). Albumin and (or) immune enhancer were not used within two weeks before operation . No blood system diseases. Exclusion Criteria: Being in the acute phase of inflammation before operation and emergency surgery. Patients combined metabolic diseases such as diabetes, hyperthyroidism, immune system disease or taking immunosuppressants; Combined hepatic insufficiency. Spleen resected in operation

    12. IPD Sharing Statement

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