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



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

For Condition: lip and oral cavity cancer,Head and Neck Cancer,Oropharyngeal Cancer
Status: Completed
Sponsor(s): Sylvester Cancer Center ,
Synopsis: 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.
Details: OBJECTIVES: I. 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 21 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven head and neck cancer undergoing definitive radiotherapy --Prior/Concurrent Therapy-- - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ArnoldMarkoe,  Study Chair,  Sylvester Cancer Center

Sylvester Cancer Center, University of Miami
Miami,  Florida,  33136
United States
 


Additional Information:
Study ID Numbers:  CDR0000078457;  SCCC-92110,NCI-V93-0288
Study Start Date: February 1993
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002533

Other Head And Neck Cancer Studies:
1. Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

2. SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck

3. Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat

4. Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer

5. Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

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