Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00892502
Status:
COMPLETED
Last Update Posted:
2013-09-10
First Post:
2009-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001729', 'term': 'Bismuth'}], 'ancestors': [{'id': 'D004603', 'term': 'Elements, Radioactive'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D011868', 'term': 'Radioisotopes'}, {'id': 'D007554', 'term': 'Isotopes'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-09', 'studyFirstSubmitDate': '2009-05-01', 'studyFirstSubmitQcDate': '2009-05-01', 'lastUpdatePostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate a possible protective effect of bismuth on the mucous membranes during chemotherapy and radiotherapy', 'timeFrame': 'daily during treatment'}], 'secondaryOutcomes': [{'measure': 'To identify the effect of bismuth on the regulation of metallothionein in tumour tissue and healthy tissue, respectively', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['haematology', 'haematological', 'hematology', 'hematological', 'malignancy', 'lymphoma', 'myeloma', 'leukemia', 'blood diseases', 'malignant', 'bismuth'], 'conditions': ['Hematological Diseases', 'Hematological Malignancies', 'Blood Diseases', 'Malignant Lymphoma', 'Leukemia', 'Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether treatment with Bismuth can reduce the toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of 18 years or over referred to the Department of Haematology L, Herlev Hospital, with a view to 'cytostatic'? treatment of or radiotherapy for haematological malignancy\n\nExclusion Criteria:\n\n* Pregnant women and nursing mothers\n* No informed consent from patient\n* Known hyper sensitivity to bismuth or other tablet content\n* Severe renal insufficiency with creatinin clearance below 25 ml/min.\n* Patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth)\n* Other experimental treatment within past four weeks."}, 'identificationModule': {'nctId': 'NCT00892502', 'acronym': 'Bismuth-PBH', 'briefTitle': 'Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy? A Clinical, Prospective, Randomized, Blinded Examination of Patients Suffering From Hematological Malignancies Treated With Intensive Chemotherapy and/or Radiotherapy.', 'orgStudyIdInfo': {'id': '2007-007652-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Bismuth tablets', 'interventionNames': ['Drug: Bismuth tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo tablets, containing no active substance', 'interventionNames': ['Drug: Placebo tablets']}], 'interventions': [{'name': 'Bismuth tablets', 'type': 'DRUG', 'description': '1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy', 'armGroupLabels': ['1']}, {'name': 'Placebo tablets', 'type': 'DRUG', 'description': '1000 mg x 2 for five days prior to chemotherapy/radiotherapy 500 mg x 2 for ten days during and after chemotherapy/radiotherapy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2650', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Haematology L, Herlev Hospital, Herlev Ringvej 75', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Per B Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Haematology, Copenhagen University Hospital at Herlev'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}