Comparing Over-the-counter Dry Mouth Remedies After Radiation

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

Detailed Description
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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.

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

Conditions
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Xerostomia

Intervention / Treatment
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* Other: sugar-free chewing gum
* Other: chewing gum
* Other: mouth rinse
* Other: mouth rinse
* Drug: mouth spray
* Drug: mouth spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.<br>* Other names: Freedent chewing gum;Other: chewing gum<br>* Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.<br>* Other names: Biotene chewing gum;Other: mouth rinse<br>* Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire<br>* Other names: Flavored water;Other: mouth rinse<br>* Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.<br>* Other names: Biotene mouth rinse;Drug: mouth spray<br>* Spray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week<br>* Other names: Salivart;Drug: mouth spray<br>* Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week<br>* Other names: MouthKote;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck cancer, Radiation therapy, Dry mouth remedies, Dry Mouth, Xerostomia