Clinical trial · Interventional
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function
Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omegaven | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Omegaven
- description
- 2 infusions of 2ml/kg, one the night before surgery and one the day after surgery
- interventionNames
- Drug: Omegaven
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBakker 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. PMID 31826232