*Effect of omega-3 fatty acids on the perioperative immune response and erythrocyte function*

Phase 4

Completed

• Conditions: Colon cancer; large bowel cancer.; 10017990; 10017991; 10017998

• Registration Number: NL-OMON40544
• Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-05-17
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

*Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
*Age between 55 and 85 years
*BMI between 20 and 35 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
*Bleeding disorders, determined by medical history and laboratory tests of clotting indices
*Metastatic disease
*Cardiac or cerebral infarction within the last 6 months
*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(s) for the use of Omegaven.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To study the effect of perioperative intravenous administration of omega-3<br /><br>fatty acids on the immune response of patients undergoing laparoscopic surgery<br /><br>for colon cancer, by measuring the ex vivo production of pro-inflammatory<br /><br>cytokine IL-6 in LPS stimulated whole blood.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To study:<br /><br>* The effect of intravenous omega-3 fatty acids on the production of TNF-* and<br /><br>IL-10 in ex vivo LPS stimulated whole blood.<br /><br>* The effect of intravenous omega-3 fatty acids on erythrocyte function.<br /><br>* The effect of intravenous omega-3 fatty acids on the in vivo systemic<br /><br>inflammatory response, including white blood cell count, C-reactive protein and<br /><br>cytokine levels in serum.<br /><br>* The effect of intravenous omega-3 fatty acids on postoperative outcome.<br /><br>* The effect of intravenous omega-3 fatty acids on cognition</p><br>