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

This study has been completed.
Sponsor:
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
  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
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
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
Peking Union Medical College Hospital
Beijing, China, 100730
Beijing Hospital
Beijing, China, 100730
Beijing Friendship Hospital
Beijing, China, 100050
People's Hospital, Beijing University
Beijing, China, 100044
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)

Additional 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:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014