Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Miami
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.
Age
21–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
