Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III, Phase II | Supportive care, Treatment | Completed | Over 21 | Other | SCCC-92110 NCI-V93-0288, NCT00002533 |
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.
Entry Criteria
Disease Characteristics:
- Histologically proven head and neck cancer undergoing definitive radiotherapy
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
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
Expected Enrollment
At least 42 patients (26 per arm) will be accrued for this study.
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.
Trial Lead Organizations
University of Miami Sylvester Comprehensive Cancer Center - Miami
 | | | ||
| Arnold Markoe, MD, ScD, Protocol chair | |
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| Registry Information | ||
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| Official Title | 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 | |
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| Trial Start Date | 1993-02-10 | |
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| Registered in ClinicalTrials.gov | NCT00002533 | |
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| Date Submitted to PDQ | 1993-02-10 | |
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| Information Last Verified | 2002-09-01 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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