Completed

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

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What is being tested

fluconazole

+ radiation therapy

DrugRadiation
Who is being recruted

Carcinoma+17

+ Carcinoma, Squamous Cell

+ Cranial Nerve Diseases

From 21 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: February 1993
See protocol details

Summary

Principal SponsorUniversity of Miami
Last updated: December 15, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00002533
Principal SponsorUniversity of Miami
Last updated: December 15, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Squamous CellCranial Nerve DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNeuroblastomaNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialOlfactory Nerve DiseasesSquamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsInfectionsEsthesioneuroblastoma, Olfactory

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sylvester Cancer Center, University of Miami

Miami, United StatesOpen Sylvester Cancer Center, University of Miami in Google Maps
CompletedOne Study Center