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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Carcinoma Surgery; Parenteral Nutrition; Post-Operative Hospital Stay	Drug: Omega-3 fish oil emulsion (Omegaven ); Drug: long-chain triglyceride	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	206 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients: A Randomized, Double Blind, Controlled, Multi-Center Clinical Trial.
Study Start Date :	June 2002
Actual Primary Completion Date :	November 2003
Actual Study Completion Date :	February 2004

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. Infectious complication [ Time Frame: POD+1 to POD+14 ]
2. Systemic inflammatory response syndrome (SIRS) [ Time Frame: POD+1 to POD +8 ]

Secondary Outcome Measures :

1. Post-operative hospitalization days [ Time Frame: POD+1 to discharge ]
2. Post operative nutritional cost & total treatment cost [ Time Frame: POD+1 to discharge ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Sino-Swed Pharmaceutical Corporation

Investigators

Study Director:	Zhu-ming Jiang, FACS	Peking Union Medical College Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

(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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	TF Ye, Ethic Committee of Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:	NCT00292279 History of Changes
Other Study ID Numbers:	HL20020004
First Posted:	February 15, 2006
Last Update Posted:	May 14, 2008
Last Verified:	May 2008

Keywords provided by Sino-Swed Pharmaceutical Corporation:

Impact of Omega 3 fatty acid on outcome; Omega-3 fatty acid; Carcinoma surgery; Digestive System; Parenteral Nutrition; Fat Emulsions, Intravenous	Clinical outcome; SIRS; Infectious complication; Postoperative hospital stay; Cost of postoperative period; Post-operative nutritional cost & total treatment cost

Additional relevant MeSH terms:

Soybean oil, phospholipid emulsion; Fat Emulsions, Intravenous; Parenteral Nutrition Solutions; Pharmaceutical Solutions