Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 21 - 120 |
| Updated: | 12/16/2016 |
| Start Date: | February 1993 |
| End Date: | August 2006 |
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
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.
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.
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.
- 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.
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
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