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

Phase 3

Completed

• Conditions: Carcinoma Surgery; Parenteral Nutrition; Post-Operative Hospital Stay
• Interventions: Drug: Omega-3 fish oil emulsion (Omegaven ); Drug: long-chain triglyceride

• Registration Number: NCT00292279
• Lead Sponsor: Sino-Swed Pharmaceutical Corporation

Brief 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.

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2003-11
• Study Completion: 2004-02
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-15
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-12
• Last Update Posted: 2008-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Post-operative male and female cancer patients
• Require post operative parenteral nutrition support at least 7 days based on nutritional risk screening(BMI 20-25)
• Sign an informed consent

Exclusion Criteria

• Diabetes Mellitus
• Abnormal fatty metabolism (TG>200mg/dl or cholesterol>240mg/dl )
• Renal dysfunction (Cr>1.6mg/dl or BUN>30mg/dl)
• Liver dysfunction (ALT>60U/L or TBIL>1.2mg/dl)
• Lienectomy
• Temperature>37.5°C
• Undergoing hormone therapy
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Omega-3 fish oil emulsion (Omegaven )	-
B	long-chain triglyceride	-

Primary Outcome Measures

Name	Time	Method
Infectious complication	POD+1 to POD+14
Systemic inflammatory response syndrome (SIRS)	POD+1 to POD +8

Secondary Outcome Measures

Name	Time	Method
Post-operative hospitalization days	POD+1 to discharge
Post operative nutritional cost & total treatment cost	POD+1 to discharge

Trial Locations

Locations (5)

Beijing Friendship Hospital; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

People's Hospital, Beijing University; 🇨🇳 Beijing, China

Beijing Hospital; 🇨🇳 Beijing, China

General Hospital Of PLA; 🇨🇳 Beijing, China