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NCT Number: NCT07478432

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location contact

Federica Ferracci, MD

SUB_INVESTIGATOR

Marco Cintoni, MD

CONTACT

[email protected]

+39 0630154365

Marco Cintoni, MD

SUB_INVESTIGATOR

Maria Cristina Mele, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Standard ONS

Dietary Supplement

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

Primary outcomes

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

    Time frame: Frome the surgical intervention to 60-days after surgery

Secondary outcomes

  1. Evaluation of variations in serum levels of specific inflammatory cytokines (IL-6, IL-10, and TNF-alpha)

    Time frame: From baseline (1 day before surgery) up to 7 days after surgery

    Cytokines will be measured with ELLA

  2. Evaluation of targeted metabolomic changes in blood (including amino acids, bile acids, and biogenic amines)

    Time frame: 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

  3. Evaluation of changes in gut microbiota composition and diversity, assessed via 16S rRNA gene sequencing of stool samples.

    Time frame: 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.

  4. Compliance with prescribed ONS (percentage of ONS taken of the total prescribed)

    Time frame: From enrollment to the day before surgery

  5. Changes in the Tumor Microenvironment Assessed by Transcriptomic Analysis

    Time frame: From the enrollment (T0) to the Cytoreductive Surgery + Hipertermic Intraperitoneal Chemotherapy (T1)

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Cintoni, MD

CONTACT

[email protected]

+39 0630154365

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

  • European Society for Clinical Nutrition and Metabolism
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Registry information

Official study title

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

Acronym: OMNI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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