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Comparing Over-the-counter Dry Mouth Remedies After Radiation

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ClinicalTrials.gov Identifier: NCT00595933
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Dini Chissoe, University of Oklahoma

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

Condition or disease Intervention/treatment Phase
Xerostomia Other: sugar-free chewing gum Other: chewing gum Other: mouth rinse Drug: mouth spray Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck
Study Start Date : March 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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 Name: Freedent chewing gum
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 Name: Biotene chewing gum
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 Name: Flavored water
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 Name: Biotene mouth rinse
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
Other Name: Salivart
Drug: mouth spray
Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
Other Name: MouthKote



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595933


Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Greg Krempl, MD University of Oklahoma

Responsible Party: Dini Chissoe, Study Coordinator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00595933     History of Changes
Other Study ID Numbers: Dry Mouth_Krempl
IRB # 12518 ( Other Identifier: Institutional Review Board )
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: June 2010

Keywords provided by Dini Chissoe, University of Oklahoma:
Head and Neck cancer
Radiation therapy
Dry mouth remedies
Dry Mouth
Xerostomia

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases