A Phase 2/3 interventional study of fluconazole and radiation therapy in Head and Neck Cancer, Infection and Oral Complications, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 21 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-12-15.
Sponsored by University of Miami · Phase 2/3, Interventional, and Treatment
RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused by radiation therapy to the head and neck.
PURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: At least 42 patients (26 per arm) will be accrued for this study.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
Browse Head and Neck Neoplasms studies →University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Not currently receiving phenytoin, hydrochlorothiazide, or warfarin
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluconazole