Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00002533|
Recruitment Status : Completed
First Posted : September 18, 2003
Last Update Posted : December 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Infection Oral Complications||Drug: fluconazole Radiation: radiation therapy||Phase 2 Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Study Start Date :||February 1993|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||August 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002533
|United States, Florida|
|Sylvester Cancer Center, University of Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Arnold M. Markoe, MD, ScD||University of Miami Sylvester Comprehensive Cancer Center|