NCT00002533

Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 21 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Infection
• Oral Complications

Interventions

Type	Name	Description
DRUG	fluconazole
RADIATION	radiation therapy

Timeline

• Start date: 1993-02-01
• Primary completion: 2006-06-01
• Completion: 2006-08-01
• First posted: 2003-09-18
• Last updated: 2016-12-15

Locations

1 site across 1 country: United States