Comparing Over-the-counter Dry Mouth Remedies After Radiation - Full Text View

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 1

University of Oklahoma has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Dry Mouth Over-the-Counter Medicines

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	March 2005
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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 Name: Salivart Other: 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

Arms

Assigned Interventions

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

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 Name: Salivart

Other: 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

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Greg Krempl, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00595933 History of Changes
Other Study ID Numbers:	Dry Mouth_Krempl, IRB # 12518
Study First Received:	December 20, 2007
Last Updated:	June 14, 2010
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013