Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
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| ClinicalTrials.gov Identifier: NCT00002533 |
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Recruitment Status :
Completed
First Posted : September 18, 2003
Last Update Posted : December 15, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer Infection Oral Complications | Drug: fluconazole Radiation: radiation therapy | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| 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 |
| Study Start Date : | February 1993 |
| Actual Primary Completion Date : | June 2006 |
| Actual Study Completion Date : | August 2006 |
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| Ages Eligible for Study: | 21 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002533
| United States, Florida | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| Study Chair: | Arnold M. Markoe, MD, ScD | University of Miami Sylvester Comprehensive Cancer Center |
| Responsible Party: | University of Miami |
| ClinicalTrials.gov Identifier: | NCT00002533 History of Changes |
| Other Study ID Numbers: |
19920577 CDR0000078457 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-V93-0288 SCCC-1992110 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center ) |
| First Posted: | September 18, 2003 Key Record Dates |
| Last Update Posted: | December 15, 2016 |
| Last Verified: | December 2016 |
Keywords provided by University of Miami:
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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 |
Additional relevant MeSH terms:
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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 |