NCT01218841

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_2 surgery

Timeline
Completed

Started Nov 2005

Typical duration for phase_2 surgery

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
Last Updated

October 11, 2010

Status Verified

October 1, 2010

Enrollment Period

3 years

First QC Date

October 8, 2010

Last Update Submit

October 8, 2010

Conditions

Surgery

Keywords

Fish oilOmega-3 fatty acidsParenteral lipid emulsionsImmune responseSurgery

Study Arms (2)

Fish oil lipid emulsion

EXPERIMENTAL

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

MCT/LCT lipid emulsion

ACTIVE COMPARATOR

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

Dietary Supplement: MCT/LCT

Interventions

Fish oil lipid emulsionDIETARY_SUPPLEMENT

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

Also known as: Omegavenos
Fish oil lipid emulsion
MCT/LCTDIETARY_SUPPLEMENT

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

Also known as: Lipovenos MCT
MCT/LCT lipid emulsion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23398953DERIVED

  • 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.

    PMID: 22282868DERIVED

Study Officials

  • Dan L. Waitzberg, PhD

    University of Sao Paulo, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 11, 2010

Study Start

November 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

October 11, 2010

Record last verified: 2010-10