Expired Study
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Miami, Florida 33136


Purpose:

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.


Study summary:

OBJECTIVES: - 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. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - 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. - 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. PROJECTED ACCRUAL: At least 42 patients (26 per arm) will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven head and neck cancer undergoing definitive radiotherapy PATIENT CHARACTERISTICS: Age: - Over 21 Performance status: - Karnofsky 70-100% Hematopoietic: - Not specified Hepatic: - SGOT and SGPT less than 2 times normal - Alkaline phosphatase less than 2 times normal Renal: - Not specified Other: - No history of hypersensitivity to fluconazole - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 2 months since prior antifungal agents - Not currently receiving phenytoin, hydrochlorothiazide, or warfarin - If these medications are initiated during study therapy, medication serum levels and electrolytes are monitored for possibility of drug interaction


NCT ID:

NCT00002533


Primary Contact:

Study Chair
Arnold M. Markoe, MD, ScD
University of Miami Sylvester Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 17, 2017

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