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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Fluconazole

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven head and neck cancer undergoing definitive radiotherapy

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

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