The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
This study has been completed.
Sponsor:
Sino-Swed Pharmaceutical Corporation
Information provided by:
Sino-Swed Pharmaceutical Corporation
ClinicalTrials.gov Identifier:
NCT00292279
First received: February 13, 2006
Last updated: May 12, 2008
Last verified: May 2008
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:
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 |
|---|---|
| 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) |
| 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
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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
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):
| 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 |
| Health Authority: | China: 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 |
Additional relevant MeSH terms:
|
Soybean oil, phospholipid emulsion Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |
ClinicalTrials.gov processed this record on September 27, 2016