Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer

Phase 2

Completed

• Conditions: Surgery
• Interventions: Dietary Supplement: Fish oil lipid emulsion; Dietary Supplement: MCT/LCT

• Registration Number: NCT01218841
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2010-10
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Last Update Submitted: 2010-10-08
• Study First Posted: 2010-10-11
• Last Update Posted: 2010-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil lipid emulsion	Fish oil lipid emulsion	Parenteral lipid emulsion composed by fish oil which is rich in the omega-3 polyunsaturated fatty acids eicosapentanoic and docosahexanoic.
MCT/LCT lipid emulsion	MCT/LCT	Parenteral lipid emulsion containing 50% of medium-chain triglycerides and 50% of soybean oil