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A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck


Phase 1
13 Years
N/A
Not Enrolling
Both
Xerostomia

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Trial Information

A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck


Xerostomia (dry mouth) is the most common late complication of radiation therapy for head
and neck cancers. When patients are cured or survive for several years, xerostomia often
becomes quite bothersome; it affects their quality of life. This study compares the
effectiveness of seven over-the-counter remedies, 2 rinses, 3 sprays and 2 chewing gums. A
computer program will make random assignments so that the patient nor the physician will
choose the order in which the products are tried. The remedies will be used for one week
each and at the end of each period the patient will fill out a questionaire.


Inclusion Criteria:



- Suffers from Xerostomia

- Surviver of head and neck cancer that received >5000 cGy radiation therapy >1 year
prior to study entry.

- Able to chew, rinse and swallow.

- Ages 13-99 years of age

Exclusion Criteria:

- Currently using the following medications: anorexiants, antiacne agents,
Anticholinergic agents, tricyclic antidepressants, chemotherapy agents.

- Unable to complete questionnaires

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.

Outcome Time Frame:

8-10 weeks

Safety Issue:

No

Principal Investigator

Greg Krempl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Institutional Review Board

Study ID:

Dry Mouth_Krempl

NCT ID:

NCT00595933

Start Date:

March 2005

Completion Date:

June 2010

Related Keywords:

  • Xerostomia
  • Head and Neck cancer
  • Radiation therapy
  • Dry mouth remedies
  • Dry Mouth
  • Xerostomia
  • Xerostomia

Name

Location
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104