Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002533
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
1999-11-01
Brief Title:
Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A PHASE IIIII PILOT STUDY OF THE EFFECTS OF PROPHYLACTIC FLUCONAZOLE THERAPY ON MUCOSITIS IN PATIENTS UNDERGOING RADIATION TREATMENT FOR HEAD AND NECK CANCER
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving fluconazole may be effective in preventing or controlling mucositis caused by radiation therapy to the head and neck
PURPOSE Randomized phase IIIII trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer
PURPOSE Randomized phase IIIII trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer
Detailed Description:
OBJECTIVES
Determine the effect of prophylactic antifungal therapy with fluconazole on the incidence and severity of radiation-associated mucositisthrush 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 5-56 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 andor 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 mucositisthrush 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 5-56 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCCC-1992110 | OTHER | University of Miami Sylvester Comprehensive Cancer Center | None |
| CDR0000078457 | REGISTRY | None | None |
| NCI-V93-0288 | None | None | None |