Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 2:37 PM
Study NCT ID:
NCT00002533
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D018304', 'term': 'Esthesioneuroblastoma, Olfactory'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020431', 'term': 'Olfactory Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-09-17', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['untreated metastatic squamous neck cancer with occult primary', 'recurrent metastatic squamous neck cancer with occult primary', 'metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'oral complications', 'stage I squamous cell carcinoma of the lip and oral cavity', 'stage I basal cell carcinoma of the lip', 'stage I verrucous carcinoma of the oral cavity', 'stage I mucoepidermoid carcinoma of the oral cavity', 'stage I adenoid cystic carcinoma of the oral cavity', 'stage II squamous cell carcinoma of the lip and oral cavity', 'stage II basal cell carcinoma of the lip', 'stage II verrucous carcinoma of the oral cavity', 'stage II mucoepidermoid carcinoma of the oral cavity', 'stage II adenoid cystic carcinoma of the oral cavity', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage III basal cell carcinoma of the lip', 'stage III verrucous carcinoma of the oral cavity', 'stage III mucoepidermoid carcinoma of the oral cavity', 'stage III adenoid cystic carcinoma of the oral cavity', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'stage IV basal cell carcinoma of the lip', 'stage IV verrucous carcinoma of the oral cavity', 'stage IV mucoepidermoid carcinoma of the oral cavity', 'stage IV adenoid cystic carcinoma of the oral cavity', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'recurrent basal cell carcinoma of the lip', 'recurrent verrucous carcinoma of the oral cavity', 'recurrent mucoepidermoid carcinoma of the oral cavity', 'recurrent adenoid cystic carcinoma of the oral cavity', 'stage I squamous cell carcinoma of the oropharynx', 'stage I lymphoepithelioma of the oropharynx', 'stage II squamous cell carcinoma of the oropharynx', 'stage II lymphoepithelioma of the oropharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage III lymphoepithelioma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'stage IV lymphoepithelioma of the oropharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'recurrent lymphoepithelioma of the oropharynx', 'stage I squamous cell carcinoma of the nasopharynx', 'stage I lymphoepithelioma of the nasopharynx', 'stage II squamous cell carcinoma of the nasopharynx', 'stage II lymphoepithelioma of the nasopharynx', 'stage III squamous cell carcinoma of the nasopharynx', 'stage III lymphoepithelioma of the nasopharynx', 'stage IV squamous cell carcinoma of the nasopharynx', 'stage IV lymphoepithelioma of the nasopharynx', 'recurrent squamous cell carcinoma of the nasopharynx', 'recurrent lymphoepithelioma of the nasopharynx', 'stage I squamous cell carcinoma of the hypopharynx', 'stage II squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the hypopharynx', 'stage I squamous cell carcinoma of the larynx', 'stage I verrucous carcinoma of the larynx', 'stage II squamous cell carcinoma of the larynx', 'stage II verrucous carcinoma of the larynx', 'stage III squamous cell carcinoma of the larynx', 'stage III verrucous carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx', 'stage IV verrucous carcinoma of the larynx', 'recurrent squamous cell carcinoma of the larynx', 'recurrent verrucous carcinoma of the larynx', 'stage I squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage I inverted papilloma of the paranasal sinus and nasal cavity', 'stage I midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'stage II squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage II inverted papilloma of the paranasal sinus and nasal cavity', 'stage II midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'stage III squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage III inverted papilloma of the paranasal sinus and nasal cavity', 'stage III midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV inverted papilloma of the paranasal sinus and nasal cavity', 'stage IV midline lethal granuloma of the paranasal sinus and nasal cavity', 'stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent inverted papilloma of the paranasal sinus and nasal cavity', 'recurrent midline lethal granuloma of the paranasal sinus and nasal cavity', 'recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity', 'infection'], 'conditions': ['Head and Neck Cancer', 'Infection', 'Oral Complications']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused by radiation therapy to the head and neck.\n\nPURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effect of prophylactic antifungal therapy with fluconazole on the incidence and severity of radiation-associated mucositis/thrush in patients with head and neck cancer undergoing definitive radiotherapy.\n\nOUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo standard hyperfractionated radiotherapy 5 days a week for 5-5.6 weeks. Patients receive oral fluconazole on days 1-4 and 28-31 of radiotherapy.\n* Arm II: Patients undergo radiotherapy as in arm I. Patients who develop a microbiologically proven fungal infection or clinically evident oral cavity and/or oropharyngeal thrush may receive fluconazole as in arm I.\n\nPROJECTED ACCRUAL: At least 42 patients (26 per arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven head and neck cancer undergoing definitive radiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 21\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* SGOT and SGPT less than 2 times normal\n* Alkaline phosphatase less than 2 times normal\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No history of hypersensitivity to fluconazole\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 2 months since prior antifungal agents\n* Not currently receiving phenytoin, hydrochlorothiazide, or warfarin\n\n * If these medications are initiated during study therapy, medication serum levels and electrolytes are monitored for possibility of drug interaction'}, 'identificationModule': {'nctId': 'NCT00002533', 'briefTitle': 'Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'A PHASE II/III PILOT STUDY OF THE EFFECTS OF PROPHYLACTIC FLUCONAZOLE THERAPY ON MUCOSITIS IN PATIENTS UNDERGOING RADIATION TREATMENT FOR HEAD AND NECK CANCER', 'orgStudyIdInfo': {'id': '19920577'}, 'secondaryIdInfos': [{'id': 'CDR0000078457', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-V93-0288'}, {'id': 'SCCC-1992110', 'type': 'OTHER', 'domain': 'University of Miami Sylvester Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluconazole', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Cancer Center, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Arnold M. Markoe, MD, ScD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Miami Sylvester Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}