Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery

NCT07478432 | Not Yet Recruiting

• 1 other identifier: ID 7814
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Carcinosis; Peritoneal Metastases; HIPEC; Cytoreductive Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification

  Frome the surgical intervention to 60-days after surgery

Secondary Outcomes (5)

• 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

• 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

• 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

• 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)

Study Arms (2)

ONS enriched with Omega-3

EXPERIMENTAL

This group receives an ONS enriched with Omega-3, 2 bottles per day for 21 days before surgery

Dietary Supplement: ONS enriched with Omega-3

Standard ONS

ACTIVE COMPARATOR

This group receives a standard ONS, 2 bottles per day for 21 days before surgery

Dietary Supplement: Standard ONS

Interventions

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

ONS enriched with Omega-3

Standard ONS DIETARY_SUPPLEMENT

300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle

Standard ONS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• European Society for Clinical Nutrition and Metabolism: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Marco Cintoni, MD

CONTACT

+39 0630154365; marco.cintoni@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Clinical Nutrition Unit, Fondazione Policlinico Agostino Gemelli, IRCCS, Rome (Italy)

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)