Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:41 PM
Study NCT ID:
NCT07478432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification', 'timeFrame': 'Frome the surgical intervention to 60-days after surgery'}], 'secondaryOutcomes': [{'measure': 'Evaluation of variations in serum levels of specific inflammatory cytokines (IL-6, IL-10, and TNF-alpha)', 'timeFrame': 'From baseline (1 day before surgery) up to 7 days after surgery', 'description': 'Cytokines will be measured with ELLA'}, {'measure': 'Evaluation of targeted metabolomic changes in blood (including amino acids, bile acids, and biogenic amines)', 'timeFrame': 'From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days', 'description': 'Assessed by the MxP® Quant 500 XL kit. This measurement quantifies over 1,000 metabolites and lipids via mass spectrometry'}, {'measure': 'Evaluation of changes in gut microbiota composition and diversity, assessed via 16S rRNA gene sequencing of stool samples.', 'timeFrame': 'From enrollment (T0) to the day before surgery (T1), an estimated period of 21 days', 'description': 'The analysis will evaluate changes in microbial alpha-diversity (e.g., Shannon index), beta-diversity, and the relative abundance of specific bacterial taxa.'}, {'measure': 'Compliance with prescribed ONS (percentage of ONS taken of the total prescribed)', 'timeFrame': 'From enrollment to the day before surgery'}, {'measure': 'Changes in the Tumor Microenvironment Assessed by Transcriptomic Analysis', 'timeFrame': 'From the enrollment (T0) to the Cytoreductive Surgery + Hipertermic Intraperitoneal Chemotherapy (T1)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritoneal Carcinosis', 'Peritoneal Metastases', 'HIPEC', 'Cytoreductive Surgery']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nWho can participate?\n\nThe 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).\n\nWhat does participating involve?\n\nUpon joining the study, participants will be randomly assigned to one of two groups:\n\n* Intervention Group: Participants will receive an Omega-3 enriched nutritional supplement called Fortimel Forticare.\n* Control Group: Participants will receive a standard nutritional supplement called Fortimel Compact Protein.\n\nBoth groups will be asked to consume two bottles of their assigned supplement per day for 21 days before the scheduled surgery.\n\nWhat will be measured?\n\nThroughout the study, the investigators will perform various assessments to monitor participant health and recovery:\n\n* 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.\n* During surgery: The investigators will collect tissue samples to study the tumor environment.\n* 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.\n\nThe study is expected to enroll a total of 28 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of peritoneal carcinomatosis from a non-gynecological primary neoplasm\n* Patients who must undergo cytoreductive surgery and HIPEC\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Patients with an enterocutaneous fistula\n* Patients with known food allergies\n* Age \\< 18 years\n* Patients with severe organ damage (e.g., kidney failure, liver failure)\n* Refusal to sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT07478432', 'acronym': 'OMNI', 'briefTitle': 'Impact of an Omega-3 Enriched Oral Nutritional Supplement on Improving Surgical Outcomes in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ID 7814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONS enriched with Omega-3', 'description': 'This group receives an ONS enriched with Omega-3, 2 bottles per day for 21 days before surgery', 'interventionNames': ['Dietary Supplement: ONS enriched with Omega-3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard ONS', 'description': 'This group receives a standard ONS, 2 bottles per day for 21 days before surgery', 'interventionNames': ['Dietary Supplement: Standard ONS']}], 'interventions': [{'name': 'ONS enriched with Omega-3', 'type': 'DIETARY_SUPPLEMENT', 'description': '300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 0.65, 1465 mg ω3 per bottle', 'armGroupLabels': ['ONS enriched with Omega-3']}, {'name': 'Standard ONS', 'type': 'DIETARY_SUPPLEMENT', 'description': '300 kcal, 18.25 g protein, 12 g lipids, ω6/ω3 ratio 5.07 per bottle', 'armGroupLabels': ['Standard ONS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Marco Cintoni, MD', 'role': 'CONTACT', 'email': 'marco.cintoni@unicatt.it', 'phone': '+39 0630154365'}, {'name': 'Maria Cristina Mele, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marco Cintoni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Federica Ferracci, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinical Nutrition Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Marco Cintoni, MD', 'role': 'CONTACT', 'email': 'marco.cintoni@unicatt.it', 'phone': '+39 0630154365'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society for Clinical Nutrition and Metabolism', 'class': 'OTHER'}, {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Clinical Nutrition Unit, Fondazione Policlinico Agostino Gemelli, IRCCS, Rome (Italy)', 'investigatorFullName': 'Maria Cristina Mele', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}