Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT03980704
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-23', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infectious complications', 'timeFrame': '6 months', 'description': 'Number and type of infectious complications'}], 'secondaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': '6 months', 'description': 'Number and type of surgical complications'}, {'measure': 'Length of stay', 'timeFrame': '14 days', 'description': 'Hospital length of stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunonutrition', 'preoperative nutrition'], 'conditions': ['General Surgery', 'Cancer of Colon']}, 'descriptionModule': {'briefSummary': 'Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.', 'detailedDescription': 'Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* resectable GI cancer\n* written consent\n\nExclusion Criteria:\n\n* inoperable GI cancer\n* known allergy to the drug'}, 'identificationModule': {'nctId': 'NCT03980704', 'acronym': 'Preop immuno', 'briefTitle': 'Preoperative High Protein vs Immunodiet in Surgical Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': "Stanley Dudrick's Memorial Hospital"}, 'officialTitle': 'Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery', 'orgStudyIdInfo': {'id': 'Imm1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Protein', 'description': 'Provision of 400 ml per day of high protein oral nutritional supplements', 'interventionNames': ['Drug: resource protein']}, {'type': 'EXPERIMENTAL', 'label': 'Immuno ONS', 'description': 'Provision of 400 ml per day of immunostimulating oral nutritional supplements', 'interventionNames': ['Drug: IMPACT']}], 'interventions': [{'name': 'IMPACT', 'type': 'DRUG', 'description': 'Administration of oral immunostimulating oral supplement', 'armGroupLabels': ['Immuno ONS']}, {'name': 'resource protein', 'type': 'DRUG', 'description': 'Administration of oral high-protein oral supplement', 'armGroupLabels': ['High Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32-050', 'city': 'Skawina', 'country': 'Poland', 'facility': "Stanley Dudrick's Memorial Hospital", 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}], 'overallOfficials': [{'name': 'Stanislaw Klek', 'role': 'STUDY_DIRECTOR', 'affiliation': "Stanley Dudrick's Memorial Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Stanley Dudrick's Memorial Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Unit', 'investigatorFullName': 'Stanislaw Klek', 'investigatorAffiliation': "Stanley Dudrick's Memorial Hospital"}}}}