NCT00292279

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

Enrollment Period

1.4 years

First QC Date

February 13, 2006

Last Update Submit

May 12, 2008

Conditions

Carcinoma SurgeryParenteral NutritionPost-Operative Hospital Stay

Keywords

Impact of Omega 3 fatty acid on outcomeOmega-3 fatty acidCarcinoma surgeryDigestive SystemParenteral NutritionFat Emulsions, IntravenousClinical outcomeSIRSInfectious complicationPostoperative hospital stayCost of postoperative periodPost-operative nutritional cost & total treatment cost

Outcome Measures

Primary Outcomes (2)

  • Infectious complication

    POD+1 to POD+14

  • Systemic inflammatory response syndrome (SIRS)

    POD+1 to POD +8

Secondary Outcomes (2)

  • Post-operative hospitalization days

    POD+1 to discharge

  • Post operative nutritional cost & total treatment cost

    POD+1 to discharge

Study Arms (2)

A

EXPERIMENTAL
Drug: Omega-3 fish oil emulsion (Omegaven )

B

ACTIVE COMPARATOR
Drug: long-chain triglyceride

Interventions

Omega-3 fish oil emulsion (Omegaven )DRUG

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

Also known as: Omegaven
A
long-chain triglycerideDRUG

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

Also known as: Intralipid
B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

People's Hospital, Beijing University

Beijing, 100044, China

Location

Beijing Friendship Hospital

Beijing, 100050, China

Location

Beijing Hospital

Beijing, 100730, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

General Hospital Of PLA

Beijing, 100853, China

Location

Related Publications (2)

  • (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)

    RESULT

  • 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.

    PMID: 20473991DERIVED

MeSH Terms

Conditions

Hyperphagia

Interventions

fish oil triglyceridessoybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zhu-ming Jiang, FACS

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 15, 2006

Study Start

June 1, 2002

Primary Completion

November 1, 2003

Study Completion

February 1, 2004

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

CN(5)