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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |

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 |
- Infectious complication [ Time Frame: POD+1 to POD+14 ]
- Systemic inflammatory response syndrome (SIRS) [ Time Frame: POD+1 to POD +8 ]
- Post-operative hospitalization days [ Time Frame: POD+1 to discharge ]
- Post operative nutritional cost & total treatment cost [ Time Frame: POD+1 to discharge ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Zhu-ming Jiang, FACS | Peking Union Medical College Hospital |
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 |
Other Study ID Numbers: |
HL20020004 |
First Posted: | February 15, 2006 Key Record Dates |
Last Update Posted: | May 14, 2008 |
Last Verified: | May 2008 |
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 |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Soybean oil, phospholipid emulsion Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |