Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function

Phase 4

Completed

• Conditions: Colon Cancer
• Interventions: Drug: Omegaven; Drug: Placebo

• Registration Number: NCT02231203
• Lead Sponsor: Medical Center Alkmaar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-09-01
• Study First Posted: 2014-09-04
• Study Start: 2014-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-28
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omegaven	Omegaven	2 infusions of 2ml/kg, one the night before surgery and one the day after surgery
Placebo	Placebo	2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.

Primary Outcome Measures

Name	Time	Method
Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood	baseline, day of surgery, postoperative day 1,2 and 4	Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine IL-6, measured in ng/ml.

Secondary Outcome Measures

Name	Time	Method
Change in erythrocyte function	baseline, day of surgery, postoperative day 1, 2 and 4	Erythrocyte deformability and aggregation measured by LORRCA (laser assisted optical rotational red cell analyzer)
Change in in vivo systemic inflammatory response parameters	baseline, day of surgery, postoperative day 1, 2 and 4	White blood cell count, C-reactive protein and cytokine levels (Interleukine-6, Tumor Necrosis Factor-α and Interleukine-10) in serum.
Change in ex vivo production of TNF-α and IL-10 in LPS stimulated whole blood	baseline, day of surgery, postoperative day 1, 2 and 4	Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine TNF-α (tumor necrosis factor-α), and the anti-inflammatory cytokine IL-10 (interleukine-10), both measured in ng/ml.

Trial Locations

Locations (1)

Medical Center of Alkmaar; 🇳🇱 Alkmaar, Noord Holland, Netherlands