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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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.

Resource links provided by NLM:

Drug Information available for: Liposyn II Liposyn III Omega-3 Fatty Acids

U.S. FDA Resources

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

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


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
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

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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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)

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
Study First Received:	February 13, 2006
Last Updated:	May 12, 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

ClinicalTrials.gov processed this record on June 26, 2017