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

NCT00002533 | Completed Phase 2 DMC

• 4 other identifiers: 19920577CDR0000078457NCI-V93-0288SCCC-1992110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Infection; Oral Complications

Keywords

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; stage I lymphoepithelioma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage II lymphoepithelioma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage III lymphoepithelioma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent lymphoepithelioma of the oropharynx; stage I squamous cell carcinoma of the nasopharynx; stage I lymphoepithelioma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage II lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent lymphoepithelioma of the nasopharynx; stage I squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I verrucous carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage II verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; stage I squamous cell carcinoma of the paranasal sinus and nasal cavity; stage I inverted papilloma of the paranasal sinus and nasal cavity; stage I midline lethal granuloma of the paranasal sinus and nasal cavity; stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage II inverted papilloma of the paranasal sinus and nasal cavity; stage II midline lethal granuloma of the paranasal sinus and nasal cavity; stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III inverted papilloma of the paranasal sinus and nasal cavity; stage III midline lethal granuloma of the paranasal sinus and nasal cavity; stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV inverted papilloma of the paranasal sinus and nasal cavity; stage IV midline lethal granuloma of the paranasal sinus and nasal cavity; stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; infection

Interventions

fluconazole DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Infections; Squamous Cell Carcinoma of Head and Neck; Esthesioneuroblastoma, Olfactory

Interventions

Fluconazole; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Arnold M. Markoe, MD, ScD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 18, 2003
• Study Start: February 1, 1993
• Primary Completion: June 1, 2006
• Study Completion: August 1, 2006
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)