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| Name | Class |
|---|---|
| European Society for Clinical Nutrition and Metabolism | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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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:
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:
The study is expected to enroll a total of 28 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONS enriched with Omega-3 | Experimental | This group receives an ONS enriched with Omega-3, 2 bottles per day for 21 days before surgery |
|
| Standard ONS | Active Comparator | This group receives a standard ONS, 2 bottles per day for 21 days before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONS enriched with Omega-3 | Dietary Supplement | 300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 0.65, 1465 mg ω3 per bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification | Frome the surgical intervention to 60-days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of variations in serum levels of specific inflammatory cytokines (IL-6, IL-10, and TNF-alpha) | Cytokines will be measured with ELLA | From baseline (1 day before surgery) up to 7 days after surgery |
| Evaluation of targeted metabolomic changes in blood (including amino acids, bile acids, and biogenic amines) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Cintoni, MD | Contact | +39 0630154365 | marco.cintoni@unicatt.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
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| Standard ONS | Dietary Supplement | 300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle |
|
Assessed by the MxP® Quant 500 XL kit. This measurement quantifies over 1,000 metabolites and lipids via mass spectrometry |
| From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days |
| 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. | From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days |
| 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) |
| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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