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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00292279
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : May 14, 2008
Sponsor:
Information provided by:
Sino-Swed Pharmaceutical Corporation

Study Description
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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

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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292279


Locations
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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
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Study Director: Zhu-ming Jiang, FACS Peking Union Medical College Hospital
More Information
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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):

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Responsible Party: TF Ye, Ethic Committee of Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00292279    
Other Study ID Numbers: HL20020004
First Posted: February 15, 2006    Key Record Dates
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:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions