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.

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 100044
    • People's Hospital, Beijing University
  • Beijing, China, 100050
    • Beijing Friendship Hospital
  • Beijing, China, 100853
    • General Hospital of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: long-chain triglyceride; the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China); Other Names: Intralipid
Experimental: A	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; Other Names: Omegaven

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Infectious complication	POD+1 to POD+14
Systemic inflammatory response syndrome (SIRS)	POD+1 to POD +8

Secondary Outcome Measures

Outcome Measure	Time Frame
Post-operative hospitalization days	POD+1 to discharge
Post operative nutritional cost & total treatment cost	POD+1 to discharge

Collaborators and Investigators

• Sponsor: Sino-Swed Pharmaceutical Corporation
• Investigators: Study Director: Zhu-ming Jiang, FACS, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• (Abstract) ZM Jiang, XR Wang, JM Wei, Y. Wang, Y. Li, S Wang, DW Wilmore. The impact of i.v. fish oil emulsion on clinical outcome & immune functions of post-operative cancer patients: a randomized, double blind, controlled, multi-center clinical trial for 203 cases Clinical Nutrition(Abstract for ESPEN 2005)(Absract No. 181)
• Jiang ZM, Wilmore DW, Wang XR, Wei JM, Zhang ZT, Gu ZY, Wang S, Han SM, Jiang H, Yu K. Randomized clinical trial of intravenous soybean oil alone versus soybean oil plus fish oil emulsion after gastrointestinal cancer surgery. Br J Surg. 2010 Jun;97(6):804-9. doi: 10.1002/bjs.6999.

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): November 1, 2003
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: February 13, 2006
• First Submitted That Met QC Criteria: February 13, 2006
• First Posted (Estimate): February 15, 2006

Study Record Updates

• Last Update Posted (Estimate): May 14, 2008
• Last Update Submitted That Met QC Criteria: May 12, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: SIRS; Parenteral Nutrition; Impact of Omega 3 fatty acid on outcome; Omega-3 fatty acid; Carcinoma surgery; Digestive System; Fat Emulsions, Intravenous; Clinical outcome; Infectious complication; Postoperative hospital stay; Cost of postoperative period; Post-operative nutritional cost & total treatment cost
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: HL20020004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No