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| Sponsored by: |
University of Oklahoma |
|---|---|
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00595933 |
Purpose
The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.
| Condition | Intervention | Phase |
|---|---|---|
|
Xerostomia |
Other: sugar-free chewing gum Other: chewing gum Other: mouth rinse Other: mouth spray |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Comparative Trial of Over-the-Counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck |
| Estimated Enrollment: | 125 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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: chewing gum
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
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: mouth rinse
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Other: 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: mouth spray
Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
|
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dini Chissoe, BS | 405-271-5504 | geraldine-chissoe@ouhsc.edu |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Greg Krempl, MD | University of Oklahoma |
More Information
| Responsible Party: | University of Oklahoma Health Sciences Center ( Greg Krempl, MD ) |
| Study ID Numbers: | Dry Mouth_Krempl, IRB # 12518 |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00595933 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Head and Neck cancer Radiation therapy Dry mouth remedies Dry Mouth Xerostomia |
|
Mouth Diseases Head and Neck Neoplasms Stomatognathic Diseases Salivary Gland Diseases Xerostomia |
