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Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer

U

University of Sao Paulo

Status and phase

Completed
Phase 2

Conditions

Surgery

Treatments

Dietary Supplement: MCT/LCT
Dietary Supplement: Fish oil lipid emulsion

Study type

Interventional

Funder types

Other

Identifiers

NCT01218841
CAPPesq 310/04

Details and patient eligibility

About

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.

Enrollment

85 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

85 participants in 2 patient groups

Fish oil lipid emulsion
Experimental group
Description:
Parenteral lipid emulsion composed by fish oil which is rich in the omega-3 polyunsaturated fatty acids eicosapentanoic and docosahexanoic.
Treatment:
Dietary Supplement: Fish oil lipid emulsion
MCT/LCT lipid emulsion
Active Comparator group
Description:
Parenteral lipid emulsion containing 50% of medium-chain triglycerides and 50% of soybean oil
Treatment:
Dietary Supplement: MCT/LCT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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