Status:
COMPLETED
Novel Rinse to Treat in Oral Candidiasis in Cancer Patients
Lead Sponsor:
Biomedical Development Corporation
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
University of Texas
Conditions:
Candidiasis, Oral
Thrush
Eligibility:
All Genders
18+ years
Brief Summary
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 ha...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Males or non-pregnant females currently receiving or post radiation therapy for head and neck cancer;
- 18 years of age;
- With signs and symptoms of oral candidiasis as determined by investigator(s);
- Females using an effective contraception method during study.
- Patients must be able and willing to comply with study requirements, and have full understanding of all elements of, and signature and dating of, informed consent prior to initiation of protocol specified procedures.
- Participating female subjects must agree to use adequate contraceptive measures during the trial. Before entering the study, women of childbearing age will be tested for pregnancy with a urine pregnancy test.
Exclusion
- History, or current evidence, of any significant acute or chronic medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation;
- Inability to use an oral rinse;
- Use of concomitant medication that, in the opinion of the Study Director, might interfere with the outcome of the study (e.g. anabolic steroids or excessive corticosteroids, large doses of aspirin (no more than one 325 mg tablet per day), phenytoin, lithium, coumadin or Iodine containing preparations \[use of iodized table salt is acceptable\]). Steroids, therapeutic doses of non-steroidal anti-inflammatory agents, estrogen therapy agents and oral contraceptives are OK to use as long as the baseline dose remains steady through the end of the study;
- Use of antifungal medication in the last 30 days, purported sensitivity or allergy to iodine;
- Pregnant or nursing patients as the effect of Iocide in the fetus or infant are not established;
- History thyroid disease.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00612963
Start Date
April 1 2007
End Date
May 1 2009
Last Update
March 8 2010
Active Locations (2)
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1
University of Missouri at Kansas City, School of Dentistry
Kansas City, Missouri, United States, 64108
2
Cancer Therapy and Researh Center
San Antonio, Texas, United States, 78229