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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44DE017301-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
| University of Texas | OTHER |
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The purpose of the study is to evaluate the efficacy of Iocide oral rinse as a treatment for Oral Candidiasis in any patient including but not limited to patients receiving radiation therapy or who have previously received radiation therapy for head and neck cancer, or patients positive for HIV/AIDS or are transplant patients.
A four-week study has been designed as an assessment of the clinical cure and mycological eradication of oral Candida isolates in 40 cancer patients referred by radiation oncologists during the course of his/her treatment. An estimated 35 patients will be evaluable at the end of the study. Candida infection is defined as positive clinical signs (white plaques) with positive potassium hydroxide (KOH) preparation and positive cultures. Colonization is defined as a positive culture without signs of clinical infection.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frio Oral Rinse | Drug | Prescription Mouth Rinse |
| Measure | Description | Time Frame |
|---|---|---|
| The primary analysis will be "intention to treat." | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure, absence of white plaque | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female volunteers who are currently receiving or post radiation therapy for head and neck cancer and currently having signs and/or symptoms of oral candidiasis
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| Name | Affiliation | Role |
|---|---|---|
| Spencer W. Redding, DDS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri at Kansas City, School of Dentistry | Kansas City | Missouri | 64108 | United States | ||
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| ID | Term |
|---|---|
| D002180 | Candidiasis, Oral |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009059 | Mouth Diseases |
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| Cancer Therapy and Researh Center |
| San Antonio |
| Texas |
| 78229 |
| United States |
| D009057 |
| Stomatognathic Diseases |