Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer; Infection; Oral Complications of Cancer and Cancer Therapy
Intervention: fluconazole (Drug); radiation therapy (Procedure)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Sylvester Cancer Center Official(s) and/or principal investigator(s):
Arnold M. Markoe, MD, ScD, Study Chair, Affiliation: Sylvester Cancer Center
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.
Clinical Details
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
Study design: Treatment, Randomized, Active Control
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
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 1993
Last updated: May 23, 2008
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