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

Parenteral Nutrition Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292279
• Other study ID #: HL20020004
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2006
• Last updated: May 12, 2008
• Start date: June 2002
• Est. completion date: February 2004

Study information

• Verified date: May 2008
• Source: Sino-Swed Pharmaceutical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: February 2004
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma Surgery
• Parenteral Nutrition
• Post-Operative Hospital Stay

Intervention

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
• long-chain triglyceride
the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing
China	Beijing Hospital	Beijing
China	General Hospital Of PLA	Beijing
China	Peking Union Medical College Hospital	Beijing
China	People's Hospital, Beijing University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sino-Swed Pharmaceutical Corporation

Country where clinical trial is conducted

China, 

References & Publications (1)

(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 fo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complication		POD+1 to POD+14	Yes
Primary	Systemic inflammatory response syndrome (SIRS)		POD+1 to POD +8	Yes
Secondary	Post-operative hospitalization days		POD+1 to discharge	Yes
Secondary	Post operative nutritional cost & total treatment cost		POD+1 to discharge	Yes