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

• ClinicalTrials.gov Identifier: NCT00002533
• Recruitment Status: Completed
• First Posted: September 18, 2003
• Last Update Posted: December 15, 2016
• Sponsor: University of Miami
• Information provided by (Responsible Party): University of Miami

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer; Infection; Oral Complications	Drug: fluconazole; Radiation: radiation therapy	Phase 2; Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Allocation: Randomized
• Primary Purpose: Treatment
• 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
• Study Start Date: February 1993
• Actual Primary Completion Date: June 2006
• Actual Study Completion Date: August 2006

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

Sylvester Cancer Center, University of Miami

Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Investigators

• Study Chair: Arnold M. Markoe, MD, ScD; University of Miami Sylvester Comprehensive Cancer Center

More Information

• Responsible Party: University of Miami
• ClinicalTrials.gov Identifier: NCT00002533
• Other Study ID Numbers: 19920577; CDR0000078457 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-V93-0288; SCCC-1992110 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
• First Posted: September 18, 2003
• Last Update Posted: December 15, 2016
• Last Verified: December 2016

Keywords provided by University of Miami:

untreated metastatic squamous neck cancer with occult primary; recurrent metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma; oral complications; stage I squamous cell carcinoma of the lip and oral cavity; stage I basal cell carcinoma of the lip; stage I verrucous carcinoma of the oral cavity; stage I mucoepidermoid carcinoma of the oral cavity; stage I adenoid cystic carcinoma of the oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage II basal cell carcinoma of the lip; stage II verrucous carcinoma of the oral cavity; stage II mucoepidermoid carcinoma of the oral cavity; stage II adenoid cystic carcinoma of the oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage III basal cell carcinoma of the lip; stage III verrucous carcinoma of the oral cavity; stage III mucoepidermoid carcinoma of the oral cavity; stage III adenoid cystic carcinoma of the oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV basal cell carcinoma of the lip; stage IV verrucous carcinoma of the oral cavity; stage IV mucoepidermoid carcinoma of the oral cavity; stage IV adenoid cystic carcinoma of the oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent basal cell carcinoma of the lip; recurrent verrucous carcinoma of the oral cavity; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent adenoid cystic carcinoma of the oral cavity; stage I squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:

Head and Neck Neoplasms; Mucositis; Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Fluconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors