Comparing Over-the-counter Dry Mouth Remedies After Radiation

Overview

The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.

Full Title of Study: “A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2010

Detailed Description

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.

Interventions

  • Other: sugar-free chewing gum
    • Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
  • Other: chewing gum
    • Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
  • Other: mouth rinse
    • Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire
  • Other: mouth rinse
    • Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
  • Drug: mouth spray
    • Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
  • Drug: mouth spray
    • Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week

Arms, Groups and Cohorts

  • Experimental: 1
    • Each participant will receive an unidentified product to use for a one week period. This will continue until all 7 dry-mouth products have been evaluated.

Clinical Trial Outcome Measures

Primary Measures

  • The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.
    • Time Frame: 8-10 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Oklahoma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Greg Krempl, MD, Principal Investigator, University of Oklahoma

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