Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Information provided by:
Biomedical Development Corporation
ClinicalTrials.gov Identifier:
NCT00612963
First received: January 30, 2008
Last updated: March 4, 2010
Last verified: August 2009
  Purpose

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.


Condition Intervention
Candidiasis, Oral
Thrush
Candidiasis
Drug: Frio Oral Rinse

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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"

Resource links provided by NLM:


Further study details as provided by Biomedical Development Corporation:

Primary Outcome Measures:
  • The primary analysis will be "intention to treat." [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical cure, absence of white plaque [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Frio Oral Rinse
    Prescription Mouth 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612963

Locations
United States, Missouri
University of Missouri at Kansas City, School of Dentistry
Kansas City, Missouri, United States, 64108
United States, Texas
Cancer Therapy and Researh Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Biomedical Development Corporation
University of Texas
Investigators
Principal Investigator: Spencer W. Redding, DDS The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: Spencer Redding, DDS, Med., UTHSCSA
ClinicalTrials.gov Identifier: NCT00612963     History of Changes
Other Study ID Numbers: HSC20070023H, 5R44DE017301-03
Study First Received: January 30, 2008
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomedical Development Corporation:
Candidiasis, Oral
Thrush
Candidiasis

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Mycoses
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 24, 2014