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

January 30, 2008
March 4, 2010
April 2007
May 2009   (final data collection date for primary outcome measure)
The primary analysis will be "intention to treat." [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00612963 on ClinicalTrials.gov Archive Site
Clinical cure, absence of white plaque [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Clinical cure, absense of white plaque [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Candidiasis, Oral
  • Thrush
  • Candidiasis
Drug: Frio Oral Rinse
Prescription Mouth Rinse
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612963
HSC20070023H, 5R44DE017301-03
No
Spencer Redding, DDS, Med., UTHSCSA
Biomedical Development Corporation
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • University of Texas
Principal Investigator: Spencer W. Redding, DDS The University of Texas Health Science Center at San Antonio
Biomedical Development Corporation
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP