Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery: A Pilot, Prospective, Randomized, Double-Blind, Controlled Study
| Registry | NCT07478432, acronym OMNI |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, supportive care |
| Enrollment | 28 (Estimated) |
| Sponsor | Catholic University of the Sacred Heart (Other); collaborators: European Society for Clinical Nutrition and Metabolism, Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Conditions | Peritoneal Carcinosis, Peritoneal Metastases, HIPEC, Cytoreductive Surgery |
| Interventions | ONS enriched with Omega-3, Standard ONS (Dietary supplement) |
| Dates | start 2026-04-01 (estimated), primary completion 2028-04-01 (estimated), completion 2028-10-01 (estimated), first posted 2026-03-17, last updated 2026-03-17 |
| Locations | 1 site in Italy |
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All trials for Peritoneal Carcinosis All trials for Peritoneal Metastases All trials of ONS enriched with Omega-3 All trials of Standard ONS
The OMNI study is a clinical trial investigating whether a nutritional supplement with added Omega-3 fatty acids can improve surgical outcomes for patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is a type of cancer that affects the abdominal lining and often requires complex and extensive surgery called cytoreductive surgery (CRS). This procedure is associated with a high risk of postoperative complications, such as infections and long hospital stays. Omega-3 fatty acids are known for their anti-inflammatory and immune-modulating properties.
The study's main goal is to see if a 21-day regimen of a pre-operative Omega-3 enriched oral nutritional supplement (ONS) can reduce postoperative complications, as measured by the Clavien-Dindo classification.
Who can participate?
The study is recruiting patients over 18 years old who have been diagnosed with non-gynecological peritoneal carcinomatosis and are scheduled to undergo cytoreductive surgery and HIPEC (hyperthermic intraperitoneal chemotherapy).
What does participating involve?
Upon joining the study, participants will be randomly assigned to one of two groups:
* Intervention Group: Participants will receive an Omega-3 enriched nutritional supplement called Fortimel Forticare.
* Control Group: Participants will receive a standard nutritional supplement called Fortimel Compact Protein.
Both groups will be asked to consume two bottles of their assigned supplement per day for 21 days before the scheduled surgery.
What will be measured?
Throughout the study, the investigators will perform various assessments to monitor participant health and recovery:
* Before and after surgery: The investigators will take body measurements, conduct a bioimpedance analysis (BIA) to check body composition, and perform a Hand Grip test to measure muscle strength. The investigators will also collect blood and stool samples.
* During surgery: The investigators will collect tissue samples to study the tumor environment.
* After surgery: The investigators will track patient recovery, including the length of the hospital stay and any complications that may occur. The investigators will also continue to monitor certain markers in the patients' blood.
The study is expected to enroll a total of 28 patients.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ONS enriched with Omega-3 | Experimental | Dietary Supplement: ONS enriched with Omega-3 | This group receives an ONS enriched with Omega-3, 2 bottles per day for 21 days before surgery |
| Standard ONS | Active comparator | Dietary Supplement: Standard ONS | This group receives a standard ONS, 2 bottles per day for 21 days before surgery |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age > 18 years * Diagnosis of peritoneal carcinomatosis from a non-gynecological primary neoplasm * Patients who must undergo cytoreductive surgery and HIPEC * Signed informed consent form Exclusion Criteria: * Patients with an enterocutaneous fistula * Patients with known food allergies * Age < 18 years * Patients with severe organ damage (e.g., kidney failure, liver failure) * Refusal to sign the informed consent form
| Facility | City | Country | Status |
|---|---|---|---|
| Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy |