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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"


N/A
18 Years
N/A
Not Enrolling
Both
Candidiasis, Oral, Thrush, Candidiasis

Thank you

Trial Information

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"


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The primary analysis will be "intention to treat."

Outcome Time Frame:

2 Weeks

Safety Issue:

Yes

Principal Investigator

Spencer W. Redding, DDS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Food and Drug Administration

Study ID:

HSC20070023H

NCT ID:

NCT00612963

Start Date:

April 2007

Completion Date:

May 2009

Related Keywords:

  • Candidiasis, Oral
  • Thrush
  • Candidiasis
  • Candidiasis, Oral
  • Thrush
  • Candidiasis
  • Candidiasis
  • Candidiasis, Oral

Name

Location

University of Missouri at Kansas City, School of DentistryKansas City, Missouri  64108
Cancer Therapy and Researh CenterSan Antonio, Texas  78229