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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00002533
First received: November 1, 1999
Last updated: July 25, 2014
Last verified: August 2013
History of Changes
  Purpose

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 Intervention Phase
Head and Neck Cancer
Infection
Oral Complications
 Drug: fluconazole
Radiation: radiation therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Fluconazole
U.S. FDA Resources

Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:
Study Start Date: February 1993
Study Completion Date: August 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility
Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002533

Locations
United States, Florida
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Arnold M. Markoe, MD, ScD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00002533     History of Changes
Other Study ID Numbers: UMIAMI-19920577  CDR0000078457  NCI-V93-0288  SCCC-1992110 
Study First Received: November 1, 1999
Last Updated: July 25, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
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

ClinicalTrials.gov processed this record on September 23, 2016