Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

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"

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.

Study Overview

• Status: Completed
• Conditions: Candidiasis; Candidiasis, Oral; Thrush
• Intervention / Treatment: Drug: Frio Oral Rinse

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 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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • University of Missouri at Kansas City, School of Dentistry
  • Texas
    • San Antonio, Texas, United States, 78229
      • Cancer Therapy and Researh Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary analysis will be "intention to treat."	2 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical cure, absence of white plaque	2 weeks

Collaborators and Investigators

• Sponsor: Biomedical Development Corporation
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); University of Texas
• Investigators: Principal Investigator: Spencer W. Redding, DDS, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 30, 2008
• First Submitted That Met QC Criteria: February 11, 2008
• First Posted (Estimate): February 12, 2008

Study Record Updates

• Last Update Posted (Estimate): March 8, 2010
• Last Update Submitted That Met QC Criteria: March 4, 2010
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Candidiasis; Candidiasis, Oral; Thrush
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Candidiasis, Oral
• Other Study ID Numbers: HSC20070023H; 5R44DE017301-03 (U.S. NIH Grant/Contract)