Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer - Full Text View

Sponsor:	University of Miami Sylvester Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002533

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Head and Neck Cancer Tonsils and Adenoids

Drug Information available for: Fluconazole

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 1993

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
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

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 - Miami

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000078457, SCCC-92110, NCI-V93-0288
Study First Received:	November 1, 1999
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00002533 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Mouth Diseases
Fluconazole
Anti-Infective Agents
Communicable Diseases
Mucositis
Gastrointestinal Diseases
Infection
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Head and Neck Neoplasms
Antifungal Agents
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on November 09, 2009