A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: sugar-free chewing gum (Other)
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.
Intervention: chewing gum (Other)
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.
Intervention: mouth rinse (Other)
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.
Intervention: mouth spray (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported