Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01168505
Status:
UNKNOWN
Last Update Posted:
2014-05-21
First Post:
2010-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C013276', 'term': 'teferrol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2010-07-21', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens', 'timeFrame': '18 weeks', 'description': 'Anemia prevention defined by hemoglobin levels'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women older than 18 years\n2. Patient with operated breast cancer with indication for (NEO)adjuvant therapy\n3. They must have hemoglobin levels within the normal range (\\> 12g/dL), absence of renal and hepatic dysfunction as assessed by serum levels of urea, creatinine, AST, ALT.\n4. Lack of folic acid deficiency and vitamin B12\n5. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Use of any oral supplement containing iron;\n2. Patients who have iron overload as defined by serum ferritin\\> 800 microg / L or transferrin saturation\\> 40%;\n3. Patients who are pregnant or breastfeeding;\n4. History of active infection or active bleeding except menstruation;\n5. History of HIV or hepatitis B or C - clinically important; -'}, 'identificationModule': {'nctId': 'NCT01168505', 'briefTitle': 'Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'NP 002/2009 - CEP 543/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'no iron supplentation'}, {'type': 'EXPERIMENTAL', 'label': 'iron supplement', 'interventionNames': ['Drug: ferric hydroxide saccharate']}], 'interventions': [{'name': 'ferric hydroxide saccharate', 'type': 'DRUG', 'otherNames': ['NORIPURUM'], 'description': 'single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses', 'armGroupLabels': ['iron supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'MAX MANO, MD PHD', 'role': 'CONTACT', 'email': 'elaine.longo@icesp.org.br', 'phone': '55-11-38932646'}, {'name': 'Aknar Calabrich, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto Do Cancer Do Estado de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01308-000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'PAULO HOFF, MD', 'role': 'CONTACT', 'email': 'rosana.batista@hsl.org.br', 'phone': '++55-11-3155-0995'}, {'name': 'PAULO HOFF, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'AKNAR CALABRICH, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Sirio Libanes', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'PAULO HOFF, MD Prof.', 'role': 'CONTACT', 'email': 'juliana.paula@icesp.org.br', 'phone': '++55-11-38932619'}, {'name': 'ROBERTO ARAI, Pharm PHD', 'role': 'CONTACT', 'email': 'roberto.arai@icesp.org.br', 'phone': '++55-11-38932619'}], 'overallOfficials': [{'name': 'Paulo Hoff, MD Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Câncer do Estado de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação Faculdade de Medicina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}