The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
NCT ID: NCT00292279
Last Updated: 2008-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2002-06-30
2004-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
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
long-chain triglyceride
the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
Interventions
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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
long-chain triglyceride
the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require post operative parenteral nutrition support at least 7 days based on nutritional risk screening(BMI 20-25)
* Sign an informed consent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Sino-Swed Pharmaceutical Corporation
INDUSTRY
Responsible Party
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Ethic Committee of Peking Union Medical College Hospital
Principal Investigators
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Zhu-ming Jiang, FACS
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
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People's Hospital, Beijing University
Beijing, , China
Beijing Friendship Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
General Hospital Of PLA
Beijing, , China
Countries
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References
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(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.
Other Identifiers
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HL20020004
Identifier Type: -
Identifier Source: org_study_id