Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Immunological Benefits of the Infusion of Pure Fish Oil Lipid Emulsion in Surgical Patients With Gastrointestinal Cancer.

Conditions
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Surgery

Intervention / Treatment
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* Dietary Supplement: Fish oil lipid emulsion
* Dietary Supplement: MCT/LCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil lipid emulsion<br>Parenteral lipid emulsion composed by fish oil which is rich in the omega-3 polyunsaturated fatty acids eicosapentanoic and docosahexanoic. | Dietary Supplement: Fish oil lipid emulsion<br>* 0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.<br>* Other names: Omegavenos;|
| Active Comparator: MCT/LCT lipid emulsion<br>Parenteral lipid emulsion containing 50% of medium-chain triglycerides and 50% of soybean oil | Dietary Supplement: MCT/LCT<br>* 0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.<br>* Other names: Lipovenos MCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish oil, Omega-3 fatty acids, Parenteral lipid emulsions, Immune response, Surgery