Clinical Trial: Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Novel Rinse to Treat Oral Candidiasis in Cancer Patients "Evaluate Iocide Oral Rinse in Any Patient With Thrush, Including But Not Limite

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 have previously received radiation therapy for head and neck cancer, or patients positive for HIV/AIDS or are transplant patients.

Detailed Summary: 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.
Sponsor: Biomedical Development Corporation

Current Primary Outcome: The primary analysis will be "intention to treat." [ Time Frame: 2 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical cure, absence of white plaque [ Time Frame: 2 weeks ]

Original Secondary Outcome: Clinical cure, absense of white plaque [ Time Frame: 2 weeks ]

Information By: Biomedical Development Corporation

Dates:
Date Received: January 30, 2008
Date Started: April 2007
Date Completion:
Last Updated: March 4, 2010
Last Verified: August 2009