---
title: Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function
nct_id: NCT02231203
overall_status: COMPLETED
phase: PHASE4
sponsor: Medical Center Alkmaar
study_type: INTERVENTIONAL
primary_condition: Colon Cancer
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02231203.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02231203"
ct_last_update_post_date: 2018-07-31
last_seen_at: "2026-05-12T06:16:18.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02231203](https://clinicaltrials.gov/study/NCT02231203)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** Medical Center Alkmaar
- **Conditions:** Colon Cancer
- **Start Date:** 2014-10
- **Completion Date:** 2016-06
- **CT.gov Last Update:** 2018-07-31

## 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

- **Minimum age:** 60 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Placebo** (PLACEBO_COMPARATOR) — 2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.
- **Omegaven** (ACTIVE_COMPARATOR) — 2 infusions of 2ml/kg, one the night before surgery and one the day after surgery

## Interventions

- **Omegaven** (DRUG) — 2 infusions, 2 ml/kg, one the night before operation and one the day after operation
- **Placebo** (DRUG) — 2 infusions, 2 ml/kg, one the night before operation and one the day after operation

## Primary Outcomes

- **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)_ — 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 Outcomes

- **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)_

## Locations (1)

- Medical Center of Alkmaar, Alkmaar, North Holland, Netherlands

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.medical center of alkmaar|alkmaar|north holland|netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02231203.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02231203*  
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