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Phase II/III Randomized Pilot Study of Fluconazole as Prophylaxis for Mucositis/Thrush in Patients With Head and Neck Cancer Undergoing Radiotherapy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Supportive care, Treatment Completed Over 21 Other SCCC-92110
NCI-V93-0288, NCT00002533

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.

Entry Criteria

Disease Characteristics:

Histologically proven head and neck cancer undergoing definitive radiotherapy

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

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

Expected Enrollment

At least 42 patients (26 per arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Arnold Markoe, MD, ScD, Protocol chair
Ph: 305-243-4319
Email: amarkoe@med.miami.edu

Registry Information

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

Trial Start Date		1993-02-10

Registered in ClinicalTrials.gov		NCT00002533

Date Submitted to PDQ		1993-02-10

Information Last Verified		2002-09-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.