NCT00292279

The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients

The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients: A Randomized, Double Blind, Controlled, Multi-Center Clinical Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Sino-Swed Pharmaceutical Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil emulsion on outcome in post-operative cancer patients.

Detailed description

As an essential component of parenteral nutrition, fat emulsion has been used more than 30 years. It provides energy and essential fatty acids. Commercial fatty emulsion products mostly come from soy bean. The omega 6 fatty acids make up with the major fatty acids of this fat emulsion, and lack of omega 3 fatty acids generally. The imbalance of these two types of fatty acids may impact with negative clinical outcomes. There are lots of omega 3 fatty acids makes up with fish oil emulsion, especially with eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA).Few clinical studies found its clinical efficacy in recently years. A commercial product of omega 3 fat emulsion by Fresenius-Kabi was registered in Europe at 1998. There is no any clinical trial in Asia to elaborate the efficacy of omega 3 fat emulsion, as well the lack of large scale clinical trial in the world. Currently study is the first large scale, randomized, double blind and multi-center clinical trial to elaborate the impact of fish oil fat emulsion in Asia and Europe.

Conditions

• Carcinoma Surgery
• Parenteral Nutrition
• Post-Operative Hospital Stay

Interventions

Type	Name	Description
DRUG	Omega-3 fish oil emulsion (Omegaven )	Patients of the treatment group received 0.2 g fish oil (10% Omegaven, Fresenius Kabi, Bad Homburg, Germany) and 1.0 g soy bean oil per kg BW per day
DRUG	long-chain triglyceride	the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)

Timeline

• Start date: 2002-06-01
• Primary completion: 2003-11-01
• Completion: 2004-02-01
• First posted: 2006-02-15
• Last updated: 2008-05-14

Locations

5 sites across 1 country: China