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Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer

NCT ID: NCT01218841

Last Updated: 2010-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-11-30

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.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fish oil lipid emulsion

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

Group Type EXPERIMENTAL

Fish oil lipid emulsion

Intervention Type DIETARY_SUPPLEMENT

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

MCT/LCT lipid emulsion

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

Group Type ACTIVE_COMPARATOR

MCT/LCT

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fish oil lipid emulsion

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

Intervention Type DIETARY_SUPPLEMENT

MCT/LCT

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omegavenos Lipovenos MCT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of São Paulo

Principal Investigators

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Dan L. Waitzberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo, Faculty of Medicine

References

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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.

Reference Type DERIVED
PMID: 23398953 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22282868 (View on PubMed)

Other Identifiers

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CAPPesq 310/04

Identifier Type: -

Identifier Source: org_study_id