Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

NCT00612963 | Completed

• 2 other identifiers: HSC20070023H5R44DE017301-03
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Candidiasis, Oral; Thrush; Candidiasis

Keywords

Candidiasis, Oral; Thrush; Candidiasis

Outcome Measures

Primary Outcomes (1)

• The primary analysis will be "intention to treat."

  2 Weeks

Secondary Outcomes (1)

• Clinical cure, absence of white plaque

  2 weeks

Interventions

Frio Oral Rinse DRUG

Prescription Mouth Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Males or non-pregnant females currently receiving or post radiation therapy for head and neck cancer;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomedical Development Corporation: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• University of Texas: collaborator

Study Sites (2)

University of Missouri at Kansas City, School of Dentistry

Kansas City, Missouri, 64108, United States

Location

Cancer Therapy and Researh Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Candidiasis, Oral; Candidiasis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Spencer W. Redding, DDS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 12, 2008
• Study Start: April 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 8, 2010

Record last verified: 2009-08

Locations

US (2)