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.
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
Patients with an enterocutaneous fistula
Patients with known food allergies
Age < 18 years
Patients with severe organ damage (e.g., kidney failure, liver failure)
Parallel
ONS enriched with Omega-3
Dietary supplement300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 0.65, 1465 mg ω3 per bottle
Standard ONS
Dietary supplement300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification
Evaluation of variations in serum levels of specific inflammatory cytokines (IL-6, IL-10, and TNF-alpha)
Cytokines will be measured with ELLA
Evaluation of targeted metabolomic changes in blood (including amino acids, bile acids, and biogenic amines)
Assessed by the MxP® Quant 500 XL kit. This measurement quantifies over 1,000 metabolites and lipids via mass spectrometry
Evaluation of changes in gut microbiota composition and diversity, assessed via 16S rRNA gene sequencing of stool samples.
The analysis will evaluate changes in microbial alpha-diversity (e.g., Shannon index), beta-diversity, and the relative abundance of specific bacterial taxa.
Compliance with prescribed ONS (percentage of ONS taken of the total prescribed)
Click on the lead sponsor to view all of their trials.
Catholic University of the Sacred Heart
Lead sponsor
European Society for Clinical Nutrition and Metabolism
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
