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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


Phase 2/Phase 3
21 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Infection, Oral Complications

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Arnold M. Markoe, MD, ScD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

EPROST-19920577

NCT ID:

NCT00002533

Start Date:

February 1993

Completion Date:

August 2006

Related Keywords:

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

Name

Location

Sylvester Cancer Center, University of MiamiMiami, Florida  33136