Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 11:28 AM
Study NCT ID:
NCT06531460
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Therapy Enriched With Omega-3 in Patients With Lung Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Use of enteral formula enriched with omega-3 or standard not revealed for participants.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 310}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-26', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day incidence infection', 'timeFrame': '30-day incidence infection following lung resection in lung cancer patients.', 'description': 'Incidence of infectious complications after surgery diagnosed using any of these criteria:\n\nInfection of surgery wound confirmed by culture Infection confirmed by blood culture Pneumonia developed after surgery confirmed by chest x Ray.'}], 'secondaryOutcomes': [{'measure': 'Changes in prostaglandin E2', 'timeFrame': 'At the beginning of nutritional therapy and at day-4 following surgery', 'description': 'Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Changes in Interleukin-6', 'timeFrame': 'At the beginning of nutritional therapy and at day-4 following surgery', 'description': 'Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Changes in Tumor Necrosis Factor Alpha (TNF-α)', 'timeFrame': 'At the beginning of nutritional therapy and at day-4 following surgery', 'description': 'Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of participants with therapeutic antibiotics prescription', 'timeFrame': 'During the hospital stay until 30-day', 'description': 'Frequency of therapeutic antibiotics prescription will be collected from medical records and medication administration registers.'}, {'measure': 'Hospital lenght of stay', 'timeFrame': 'During the hospital stay until 90-day', 'description': 'Number of calendar days that elapsed since hospital admission to the day of hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'omega-3', 'prehabilitation nutrition', 'perioperative nutrition', 'infections', 'inflammation response'], 'conditions': ['Lung Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lung cancer diagnosis\n* Elective surgery for lung resection schedule at least four days before surgery\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Acute or chronic organ failure as hepatic or renal insufficiency\n* Patients with fish-allergy\n* History of any surgery within 3 months\n* Immunocompromised patients'}, 'identificationModule': {'nctId': 'NCT06531460', 'briefTitle': 'Nutritional Therapy Enriched With Omega-3 in Patients With Lung Resection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Respiratory Diseases, Mexico'}, 'officialTitle': 'Effect of Perioperative Nutrition Enriched With Omega-3 on the Incidence of Infections in Oncologic Patients Following Lung Resection', 'orgStudyIdInfo': {'id': 'C34-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental enteral nutrition', 'description': 'Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula', 'interventionNames': ['Dietary Supplement: Fish oil enteral supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental oral nutrition', 'description': 'Patients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery', 'interventionNames': ['Dietary Supplement: Fish oil oral supplementation']}, {'type': 'OTHER', 'label': 'Standard enteral nutrition', 'description': 'Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula', 'interventionNames': ['Dietary Supplement: Enteral nutrition without fish oil']}, {'type': 'OTHER', 'label': 'Standard oral nutrition', 'description': 'Patients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery', 'interventionNames': ['Dietary Supplement: Oral nutritional supplement without fish oil']}], 'interventions': [{'name': 'Fish oil enteral supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Omega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery', 'armGroupLabels': ['Experimental enteral nutrition']}, {'name': 'Fish oil oral supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Omega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery', 'armGroupLabels': ['Experimental oral nutrition']}, {'name': 'Enteral nutrition without fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Enteral formula without omega-3 administered through an enteral feeding tube, three days before surgery', 'armGroupLabels': ['Standard enteral nutrition']}, {'name': 'Oral nutritional supplement without fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery', 'armGroupLabels': ['Standard oral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Ana L Gomez-Rodriguez, MSc', 'role': 'CONTACT', 'email': 'grolucia@yahoo.es', 'phone': '+52 1 55 2573 2734'}], 'facility': 'National Institute of Respiratory Diseases', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Ivan A Osuna-Padilla, PhD', 'role': 'CONTACT', 'email': 'ivan.osuna@iner.gob.mx', 'phone': '5487-1700', 'phoneExt': '5059'}, {'name': 'Ana L Gómez-Rodriguez, MSc', 'role': 'CONTACT', 'email': 'grolucia@yahoo.es', 'phone': '5487-1700', 'phoneExt': '5059'}], 'overallOfficials': [{'name': 'Ivan A Osuna-Padilla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Enfermedades Respiratorias'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Respiratory Diseases, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Nutrition Manager', 'investigatorFullName': 'Ivan Armando Osuna Padilla', 'investigatorAffiliation': 'National Institute of Respiratory Diseases, Mexico'}}}}