Cytoreductive Surgery, HIPEC, Peritoneal Carcinosis, Peritoneal Metastases
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTONS enriched with Omega-3
300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 0.65, 1465 mg ω3 per bottle
DIETARY_SUPPLEMENTStandard ONS
300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle
Sponsors
Catholic University of the Sacred Heart
European Society for Clinical Nutrition and Metabolism
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification | Frome the surgical intervention to 60-days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of variations in serum levels of specific inflammatory cytokines (IL-6, IL-10, and TNF-alpha) | From baseline (1 day before surgery) up to 7 days after surgery | Cytokines will be measured with ELLA |
| Evaluation of targeted metabolomic changes in blood (including amino acids, bile acids, and biogenic amines) | From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days | 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. | From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days | 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) | From enrollment to the day before surgery | — |
| Changes in the Tumor Microenvironment Assessed by Transcriptomic Analysis | From the enrollment (T0) to the Cytoreductive Surgery + Hipertermic Intraperitoneal Chemotherapy (T1) | — |
Countries
Italy
Contacts
CONTACTMarco Cintoni, MD
Outcome results
None listed