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

NCT ID: NCT00002533

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1993-02-28

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer Infection Oral Complications

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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fluconazole

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnold M. Markoe, MD, ScD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

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Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000078457

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V93-0288

Identifier Type: -

Identifier Source: secondary_id

SCCC-1992110

Identifier Type: OTHER

Identifier Source: secondary_id

19920577

Identifier Type: -

Identifier Source: org_study_id