Clinical trial NCT02231203: Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function
Official title: Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Cancer
Keywords: fish oil
omega-3 fatty acids
postoperative inflammatory response
erythrocyte function
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood
timeFrame: 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
timeFrame: baseline, day of surgery, postoperative day 1, 2 and 4
measure: Change in erythrocyte function
timeFrame: baseline, day of surgery, postoperative day 1, 2 and 4
measure: Change in in vivo systemic inflammatory response parameters
timeFrame: baseline, day of surgery, postoperative day 1, 2 and 4
Other outcomes:
measure: Postoperative outcome (composite measure of length of stay and complications)
timeFrame: Registration during admission, follow up 2 and 4 weeks after surgery
measure: Cognitive function
timeFrame: baseline, follow up 2 weeks after surgery
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center of Alkmaar
state: Noord Holland
Study officials:
affiliation: Medical Center of Alkmaar
name: A.P.J. Houdijk, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakker N, van den Helder RS, Stoutjesdijk E, van Pelt J, Houdijk APJ. Effects of perioperative intravenous omega-3 fatty acids in colon cancer patients: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2020 Feb 1;111(2):385-395. doi: 10.1093/ajcn/nqz281.