CClinicalTrials.gg
CompletedNCT00612963Updated Mar 8, 2010

Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

An observational study in Candidiasis, Oral, Thrush and Candidiasis, sponsored by Biomedical Development Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-08.

Sponsored by Biomedical Development Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
23
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Candidiasis, Oral
  • Thrush
  • Candidiasis

Keywords

  • Candidiasis, Oral
  • Thrush
  • Candidiasis
03

In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's enrollment of 23 is below the median of 123 across 63 observational studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Biomedical Development Corporation is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
23 participants (actual)

Interventions

  • DrugFrio Oral Rinse

    Prescription Mouth Rinse

06

What researchers measure

Primary outcomes

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

    Time frame: 2 Weeks

Secondary outcomes

  1. Clinical cure, absence of white plaque

    Time frame: 2 weeks

07

Study locations

2 sites
  • University of Missouri at Kansas City, School of Dentistry
    Kansas City, Missouri 64108, United States
  • Cancer Therapy and Researh Center
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00612963
Lead sponsor
Biomedical Development Corporation
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR), University of Texas
First posted
Feb 12, 2008
Start date
Apr 2007
Primary completion
May 2009
Completion
May 2009
Last update
Mar 8, 2010

Study contacts

Spencer W. Redding, DDS
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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