Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery

A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.

Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.

Study Overview

• Status: Completed
• Conditions: GI Cancer
• Intervention / Treatment: Drug: MLF 541; Drug: Lipofundin MCT

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital Taipei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients considered for major surgery for gastric and colorectal cancer
• expected requirement for post operative PN or TPN of at least 7 days
• possibility of PN/TPN provision 1 day prior to surgery
• Age >18 years old and <80 years old
• Hemodynamically stable
• Written Informed consent

Exclusion Criteria:

• Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study
• Patients with sepsis, severe sepsis or septic shock
• Known or suspected drug abuse
• Intrahepatic cholestasis
• General contraindications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency
• Pregnancy (positive in urine) or lactation
• Autoimmune disease e.g. HIV
• Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients of the investigational products
• Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
• Alterations of coagulation (thrombocytes <150000 /mm3), PT < 50%, PTT > 40 sec
• Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
• Renal insufficiency with serum creatinine > 1.4 mg/dL (>124 µmol/L)
• Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (> 43 µmol/L)
• Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.85 mmol/L),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lipid emulsion with n-3 FA	Drug: MLF 541; 22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
Active Comparator: lipid emulsion without n-3 FA	Drug: Lipofundin MCT; 22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reduction of pro inflammatory activity	30 days

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Collaborators: B.Braun Taiwan Co., Ltd.

Publications and helpful links

General Publications

• Ma CJ, Wu JM, Tsai HL, Huang CW, Lu CY, Sun LC, Shih YL, Chen CW, Chuang JF, Wu MH, Wang MY, Lin MT, Wang JY. Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients. Nutr J. 2015 Jan 21;14:9. doi: 10.1186/1475-2891-14-9.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: November 25, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): June 9, 2011
• Last Update Submitted That Met QC Criteria: June 8, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: post OP
• Other Study ID Numbers: HC-G-H-0603