search
Back to results

Comparing Over-the-counter Dry Mouth Remedies After Radiation

Primary Purpose

Xerostomia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sugar-free chewing gum
chewing gum
mouth rinse
mouth rinse
mouth spray
mouth spray
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Head and Neck cancer, Radiation therapy, Dry mouth remedies, Dry Mouth, Xerostomia

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
September 1, 2022
Sponsor
University of Oklahoma
search

1. Study Identification

Unique Protocol Identification Number
NCT00595933
Brief Title
Comparing Over-the-counter Dry Mouth Remedies After Radiation
Official Title
A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
Head and Neck cancer, Radiation therapy, Dry mouth remedies, Dry Mouth, Xerostomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
sugar-free chewing gum
Other Intervention Name(s)
Freedent chewing gum
Intervention Description
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Intervention Type
Other
Intervention Name(s)
chewing gum
Other Intervention Name(s)
Biotene chewing gum
Intervention Description
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Intervention Type
Other
Intervention Name(s)
mouth rinse
Other Intervention Name(s)
Flavored water
Intervention Description
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire
Intervention Type
Other
Intervention Name(s)
mouth rinse
Other Intervention Name(s)
Biotene mouth rinse
Intervention Description
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Intervention Type
Drug
Intervention Name(s)
mouth spray
Other Intervention Name(s)
Salivart
Intervention Description
Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
Intervention Type
Drug
Intervention Name(s)
mouth spray
Other Intervention Name(s)
MouthKote
Intervention Description
Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Krempl, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparing Over-the-counter Dry Mouth Remedies After Radiation

We'll reach out to this number within 24 hrs