Comparing Over-the-counter Dry Mouth Remedies After Radiation

September 1, 2022 updated by: University of Oklahoma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Freedent chewing gum
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 Names:
  • Biotene chewing gum
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 Names:
  • Flavored water
Other: mouth rinse
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Other Names:
  • Biotene mouth rinse
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
Other Names:
  • Salivart
Drug: mouth spray
Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
Other Names:
  • MouthKote

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8-10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Greg Krempl, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

January 2, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dry Mouth_Krempl
  • IRB # 12518 (Other Identifier: Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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