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

University of Miami

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infection; Oral Complications; Head and Neck Cancer

Treatments: Drug: fluconazole; Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00002533

NCI-V93-0288

CDR0000078457 (Registry Identifier)

SCCC-1992110 (Other Identifier)

19920577

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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