Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-04-17 @ 12:15 PM
Study NCT ID:
NCT01477866
Status:
SUSPENDED
Last Update Posted:
2017-12-12
First Post:
2011-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'whyStopped': 'the study has never started', 'overallStatus': 'SUSPENDED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'lastUpdateSubmitDate': '2017-12-09', 'studyFirstSubmitDate': '2011-11-18', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colonic Neoplasms']}, 'descriptionModule': {'briefSummary': 'The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.', 'detailedDescription': 'CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). These subspecies of probiotics bacteria have been shown to be effective in improving the immunity. Several trials are currently underway, in order to evaluate the effects of probiotics as potential novel therapies in addition to traditional therapeutic approaches. Although probiotics do not play an anti-tumor action per se, these agents may significantly contribute to decrease the typical side effects due to traditional anti-tumor treatments, such as gastrointestinal symptoms, immunity deficit, as well as the alterations in the gut lymphoid tissue.\n\nIt is therefore expected that CITOGENEX may have several significant beneficial effects in patients under anti-tumor treatments. In order to test this hypothesis, we will perform a randomized, single-blind, two-arms, prospective study in patients with colon-rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage IIIa-IIIc (AJCC/TNM)'}, 'identificationModule': {'nctId': 'NCT01477866', 'acronym': 'CITOGENEX PA', 'briefTitle': 'Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer', 'orgStudyIdInfo': {'id': 'CITOGENEX CRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'citogenex', 'description': 'citogenex + conventional therapy', 'interventionNames': ['Dietary Supplement: citogenex', 'Other: conventional therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional therapy', 'description': 'conventional therapy', 'interventionNames': ['Other: conventional therapy']}], 'interventions': [{'name': 'citogenex', 'type': 'DIETARY_SUPPLEMENT', 'description': 'CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type).', 'armGroupLabels': ['citogenex']}, {'name': 'conventional therapy', 'type': 'OTHER', 'description': 'conventional therapy for colon-rectal cancer', 'armGroupLabels': ['citogenex', 'conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90129', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'University of Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'overallOfficials': [{'name': 'Giovanni Tomasello, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Palermo'}, {'name': 'Francesco Cappello, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Palermo'}, {'name': 'Provvidenza Damiani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Palermo'}, {'name': 'Manfredi Rizzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Palermo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manfredi Rizzo', 'investigatorAffiliation': 'University of Palermo'}}}}