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Sponsors and Collaborators: |
Biomedical Development Corporation National Institute of Dental and Craniofacial Research (NIDCR) UTHSCSA |
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Information provided by: | Biomedical Development Corporation |
ClinicalTrials.gov Identifier: | NCT00612963 |
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.
Condition | Intervention |
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Candidiasis, Oral Thrush Candidiasis |
Drug: Frio Oral Rinse |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Novel Rinse to Treat Oral Candidiasis in Cancer Patients "Evaluate Iocide Oral Rinse in Any Patient With Thrush, Including But Not Limited to Patients Currently Receiving or Post Radiation Therapy for Head and Neck Cancer or Patients Positive for HIV/AIDS or Transplant Patients" |
Estimated Enrollment: | 40 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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
Inclusion Criteria:
Exclusion Criteria:
Contact: Spencer W Redding, DDS | 210-567-3345 | redding@uthscsa.edu |
Contact: Leonard Lausten, DDS | 816-235-2160 | laustenl@umkc.edu |
United States, Missouri | |
University of Missouri at Kansas City, School of Dentistry | Recruiting |
Kansas City, Missouri, United States, 64108 | |
Contact: Leonard Lausten, DDS 816-235-2160 laustenl@umkc.edu | |
Contact: Kathryn M. Dockter, M.S., RDH 816-235-2300 kmd1d2@umkc.edu | |
Sub-Investigator: Leonard Lausten, DDS | |
United States, Texas | |
Cancer Therapy and Researh Center | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Biomedical Development Corporation 210-308-0636 gsiegel@biodevcorp.com | |
Principal Investigator: Spencer W. Redding, DDS |
Principal Investigator: | Spencer W. Redding, DDS | University of Texas |
Responsible Party: | UTHSCSA ( Spencer Redding, DDS, Med. ) |
Study ID Numbers: | HSC20070023H, 5R44DE017301-03 |
Study First Received: | January 30, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00612963 |
Health Authority: | United States: Food and Drug Administration |
Candidiasis, Oral Thrush Candidiasis |
Mouth Diseases Mycoses Candidiasis, Oral Candidiasis |
HIV Infections Head and Neck Neoplasms Acquired Immunodeficiency Syndrome Stomatognathic Diseases |