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

Sponsored by:	Sino-Swed Pharmaceutical Corporation
Information provided by:	Sino-Swed Pharmaceutical Corporation
ClinicalTrials.gov Identifier:	NCT00292279

Purpose

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	Intervention	Phase
Carcinoma Surgery Parenteral Nutrition Post-Operative Hospital Stay	Drug: Omega-3 fish oil emulsion (Omegaven ) Drug: long-chain triglyceride	Phase III

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Sino-Swed Pharmaceutical Corporation:

Primary Outcome Measures:

Infectious complication [ Time Frame: POD+1 to POD+14 ] [ Designated as safety issue: Yes ]
Systemic inflammatory response syndrome (SIRS) [ Time Frame: POD+1 to POD +8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Post-operative hospitalization days [ Time Frame: POD+1 to discharge ] [ Designated as safety issue: Yes ]
Post operative nutritional cost & total treatment cost [ Time Frame: POD+1 to discharge ] [ Designated as safety issue: Yes ]

Enrollment:	206
Study Start Date:	June 2002
Study Completion Date:	February 2004
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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
B: Active Comparator	Drug: long-chain triglyceride the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292279

Locations

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

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)

Responsible Party:	Ethic Committee of Peking Union Medical College Hospital ( TF Ye )
Study ID Numbers:	HL20020004
Study First Received:	February 13, 2006
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00292279 History of Changes
Health Authority:	China: State Food and Drug Administration

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

Study placed in the following topic categories:

Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009