Overview

This trial is active, not recruiting.

Condition colon cancer
Treatments omegaven, placebo
Phase phase 4
Sponsor Medical Center Alkmaar
Start date October 2014
End date June 2016
Trial size 44 participants
Trial identifier NCT02231203, NL46230.029.13

Summary

Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. They modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing.

The investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.
placebo NaCl 0,9%
2 infusions, 2 ml/kg, one the night before operation and one the day after operation
(Active Comparator)
2 infusions of 2ml/kg, one the night before surgery and one the day after surgery
omegaven purified fish oil
2 infusions, 2 ml/kg, one the night before operation and one the day after operation

Primary Outcomes

Measure
Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood
time frame: baseline, day of surgery, postoperative day 1,2 and 4

Secondary Outcomes

Measure
Change in ex vivo production of TNF-α and IL-10 in LPS stimulated whole blood
time frame: baseline, day of surgery, postoperative day 1, 2 and 4
Change in erythrocyte function
time frame: baseline, day of surgery, postoperative day 1, 2 and 4
Change in in vivo systemic inflammatory response parameters
time frame: baseline, day of surgery, postoperative day 1, 2 and 4

Eligibility Criteria

Male or female participants from 60 years up to 80 years old.

Inclusion Criteria: - Patients (male or female) undergoing elective laparoscopic surgery for colon cancer - Age between 60 and 80 years - BMI between 20 kg/m2 and below 30 kg/m2 - Written informed consent Exclusion Criteria: - Participation in or having participated in another clinical trial within the previous 3 months - Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve - Pre-operative Hemoglobin<5.0 mmol/L - Metastatic disease - Very poor peripheral venous access - Current history of inflammatory or infectious disease - The use of anti-inflammatory drugs - The use of thyroid medication - The use of fish oil products or fish consumption more than 2 times a week - Contra-indication for the use of Omegaven-Fresenius, including: - General contra-indications for parenteral nutrition - Allergy to fish or egg protein.

Additional Information

Official title Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer
Principal investigator A.P.J. Houdijk, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medical Center Alkmaar.