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

Head and Neck Cancer 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002533
• Other study ID #: 19920577
• Secondary ID: CDR0000078457NCI
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 1, 1999
• Last updated: December 14, 2016
• Start date: February 1993
• Est. completion date: August 2006

Study information

• Verified date: December 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Infection
• Mucositis
• Oral Complications

Intervention

Drug:
• fluconazole

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Sylvester Cancer Center, University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States,