Comparing Over-the-counter Dry Mouth Remedies After Radiation

Phase 1

Completed

• Conditions: Xerostomia
• Interventions: Other: sugar-free chewing gum; Other: chewing gum; Other: mouth rinse; Drug: mouth spray

• Registration Number: NCT00595933
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-16
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	mouth spray	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.
1	chewing gum	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.
1	sugar-free chewing gum	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.
1	mouth rinse	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States