Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Ca… (NCT00002533) | Clinical Trial Compass
CompletedPhase 2/3
Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
United StatesStarted 1993-02
Plain-language summary
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.
Who can participate
Age range21 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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