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Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer

Primary Purpose

Surgery

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fish oil lipid emulsion
MCT/LCT
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Fish oil, Omega-3 fatty acids, Parenteral lipid emulsions, Immune response, Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Elective surgical patients with confirmed (biopsy) gastrointestinal (colon or stomach) cancer; 30-75 years old; venous assess to blood collections (40 mL) to receive parenteral infusions of lipid emulsion; Karnofsky performance statuses of ≥60

Exclusion Criteria:

Intolerance or allergy to any ingredient in lipid emulsion; diagnosis of infectious, inflammatory, immunologic or metabolic diseases; dementia;medicine intake that could significantly modulate metabolism; implanted electromagnetic instruments.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fish oil lipid emulsion

    MCT/LCT lipid emulsion

    Arm Description

    Parenteral lipid emulsion composed by fish oil which is rich in the omega-3 polyunsaturated fatty acids eicosapentanoic and docosahexanoic.

    Parenteral lipid emulsion containing 50% of medium-chain triglycerides and 50% of soybean oil

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2010
    Last Updated
    October 8, 2010
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01218841
    Brief Title
    Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer
    Official Title
    Clinical and Immunological Benefits of the Infusion of Pure Fish Oil Lipid Emulsion in Surgical Patients With Gastrointestinal Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Surgical trauma can lead to an intense inflammation and impairment of the capacity to fight against infections. Fish oil is composed by substances called omega-3 fatty acids which have anti-inflammatory effects. When infused through the vein as part of a nutritional treatment of some surgical patients, fish oil have been shown to preserve some defense capabilities against infections and to decrease postoperative release of inflammatory substances, contributing to the shortening of length of hospital and intensive care unity (ICU) stay and complications, mainly infectious complications. These reported benefits have been encouraging the vein infusion of fish oil as a kind of medicine to contribute for the treatment of surgical patients. In current study the investigators evaluated the effect of preoperative infusion of pure fish oil in patients with gastrointestinal cancer (stomach and colon) on their clinical outcomes. The hypothesis considered that preoperative infusion of fish oil, not as part of nutritional therapy but as a medicine agent, can attenuates inflammation and improves the capacity of surgical patients to fight against infections, improving their treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgery
    Keywords
    Fish oil, Omega-3 fatty acids, Parenteral lipid emulsions, Immune response, Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    85 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fish oil lipid emulsion
    Arm Type
    Experimental
    Arm Description
    Parenteral lipid emulsion composed by fish oil which is rich in the omega-3 polyunsaturated fatty acids eicosapentanoic and docosahexanoic.
    Arm Title
    MCT/LCT lipid emulsion
    Arm Type
    Active Comparator
    Arm Description
    Parenteral lipid emulsion containing 50% of medium-chain triglycerides and 50% of soybean oil
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fish oil lipid emulsion
    Other Intervention Name(s)
    Omegavenos
    Intervention Description
    0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    MCT/LCT
    Other Intervention Name(s)
    Lipovenos MCT
    Intervention Description
    0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elective surgical patients with confirmed (biopsy) gastrointestinal (colon or stomach) cancer; 30-75 years old; venous assess to blood collections (40 mL) to receive parenteral infusions of lipid emulsion; Karnofsky performance statuses of ≥60 Exclusion Criteria: Intolerance or allergy to any ingredient in lipid emulsion; diagnosis of infectious, inflammatory, immunologic or metabolic diseases; dementia;medicine intake that could significantly modulate metabolism; implanted electromagnetic instruments.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan L. Waitzberg, PhD
    Organizational Affiliation
    University of Sao Paulo, Faculty of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23398953
    Citation
    de Miranda Torrinhas RS, Santana R, Garcia T, Cury-Boaventura MF, Sales MM, Curi R, Waitzberg DL. Parenteral fish oil as a pharmacological agent to modulate post-operative immune response: a randomized, double-blind, and controlled clinical trial in patients with gastrointestinal cancer. Clin Nutr. 2013 Aug;32(4):503-10. doi: 10.1016/j.clnu.2012.12.008. Epub 2012 Dec 22.
    Results Reference
    derived
    PubMed Identifier
    22282868
    Citation
    Cury-Boaventura MF, Torrinhas RS, de Godoy AB, Curi R, Waitzberg DL. Human leukocyte death after a preoperative infusion of medium/long-chain triglyceride and fish oil parenteral emulsions: a randomized study in gastrointestinal cancer patients. JPEN J Parenter Enteral Nutr. 2012 Nov;36(6):677-84. doi: 10.1177/0148607111432759. Epub 2012 Jan 26.
    Results Reference
    derived

    Learn more about this trial

    Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer

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