Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
- Conditions
- Oral ComplicationsInfectionHead and Neck Cancer
- Registration Number
- NCT00002533
- Lead Sponsor
- University of Miami
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States