Peritoneal CarcinosisOMNINCT07478432
Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery
A study testing ONS enriched with Omega-3 and Standard ONS in people with Peritoneal Carcinosis and Peritoneal Metastases, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinosis, Peritoneal Metastases, HIPEC
- What is being tested?
- ONS enriched with Omega-3 and Standard ONS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Marco Cintoni, MD, +39 0630154365, marco.cintoni@unicatt.it
Maria Cristina Mele, MD
About this study
Official 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
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.
Read more
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.
- Being tested
- ONS enriched with Omega-3, Standard ONS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONS enriched with Omega-3Dietary supplement
300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 0.65, 1465 mg ω3 per bottle
Standard ONSDietary supplement
300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle
| Study group | Role | What they receive |
|---|---|---|
| ONS enriched with Omega-3 | Experimental | This group receives an ONS enriched with Omega-3, 2 bottles per day for 21 days before surgery Receives: 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 Receives: Dietary Supplement: Standard ONS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification
Measured: 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)
Cytokines will be measured with ELLA
Measured: 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)
Assessed by the MxP® Quant 500 XL kit. This measurement quantifies over 1,000 metabolites and lipids via mass spectrometry
Measured: 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.
Measured: 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)
Measured: From enrollment to the day before surgery
Changes in the Tumor Microenvironment Assessed by Transcriptomic Analysis
Measured: From the enrollment (T0) to the Cytoreductive Surgery + Hipertermic Intraperitoneal Chemotherapy (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Maria Cristina Mele, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478432
- Sponsor's protocol ID
- ID 7814
- Acronym
- OMNI
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07478432
- Acronym / sponsor ID
- OMNI / ID 7814
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS enriched with Omega-3 | Experimental | Dietary Supplement: ONS enriched with Omega-3This group receives an ONS enriched with Omega-3, 2 bottles per day for 21 days before surgery |
| Standard ONS | Active comparator | Dietary Supplement: Standard ONSThis group receives a standard ONS, 2 bottles per day for 21 days before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONS enriched with Omega-3300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 0.65, 1465 mg ω3 per bottle | Dietary supplement | ONS enriched with Omega-3 |
| Standard ONS300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle | Dietary supplement | Standard ONS |
Primary outcome
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification
Time frame: Frome the surgical intervention to 60-days after surgery
5 secondary outcomes
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
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
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
Compliance with prescribed ONS (percentage of ONS taken of the total prescribed)
Time frame: From enrollment to the day before surgery
Changes in the Tumor Microenvironment Assessed by Transcriptomic Analysis
Time frame: From the enrollment (T0) to the Cytoreductive Surgery + Hipertermic Intraperitoneal Chemotherapy (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS enriched with Omega-3 and Standard ONS in people with Peritoneal Carcinosis and Peritoneal Metastases, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Cintoni, MD (+39 0630154365, marco.cintoni@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification (time frame: Frome the surgical intervention to 60-days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.