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NCT00595933 Clinical Trial

Comparing Over-the-counter Dry Mouth Remedies After Radiation

Xerostomia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00595933
Other study ID # Dry Mouth_Krempl
Secondary ID IRB # 12518
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2005
Est. completion date June 2010

Study information
Verified date September 2022
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• chewing gum
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
• mouth rinse
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire
• mouth rinse
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
Drug:
• 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
• mouth spray
Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week

Locations
Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT00656513 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer Phase 2/Phase 3
Completed NCT00911768 - Effect of Korean Red Ginseng (KRG) on Dry Mouth Phase 4
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Completed NCT05247008 - Effectiveness of Thyme Honey in Management of Xerostomia in ESRD N/A
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Active, not recruiting NCT03176368 - Coconut Oil: Managing Radiation-Induced Xerostomia N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03611283 - Topical Management of Xerostomia With Dry Mouth Products N/A
Completed NCT02682199 - Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Withdrawn NCT01960101 - Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication N/A
Completed NCT02317172 - Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases N/A