Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01218841

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Dietary Supplement: Fish oil lipid emulsion Dietary Supplement: MCT/LCT	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fish oil lipid emulsion 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 0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein. Other Names: Omegavenos
Active Comparator: MCT/LCT lipid emulsion Parenteral lipid emulsion containing 50% of medium-chain triglycerides and 50% of soybean oil	Dietary Supplement: MCT/LCT 0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein. Other Names: Lipovenos MCT

Arm

Intervention/Treatment

Experimental: Fish oil lipid emulsion

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

0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.

Other Names:

Omegavenos

Active Comparator: MCT/LCT lipid emulsion

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

Dietary Supplement: MCT/LCT

0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.

Other Names:

Lipovenos MCT

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.