Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

Candidiasis Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612963
• Other study ID #: HSC20070023H
• Secondary ID: 5R44DE017301-03
• Status: Completed
• Phase: N/A
• First received: January 30, 2008
• Last updated: March 4, 2010
• Start date: April 2007
• Est. completion date: May 2009

Study information

• Verified date: August 2009
• Source: Biomedical Development Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• Thrush

Intervention

Drug:
• Frio Oral Rinse
Prescription Mouth Rinse

Locations

Country	Name	City	State
United States	University of Missouri at Kansas City, School of Dentistry	Kansas City	Missouri
United States	Cancer Therapy and Researh Center	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Biomedical Development Corporation	National Institute of Dental and Craniofacial Research (NIDCR), University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary analysis will be "intention to treat."		2 Weeks	Yes
Secondary	Clinical cure, absence of white plaque		2 weeks	Yes