Comparing Over-the-counter Dry Mouth Remedies After Radiation

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT00595933

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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 Other: mouth rinse Drug: mouth spray 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 Design

Study Type:

Interventional

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 :

Mar 1, 2005

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: MouthKote

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 Names:

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 Names:

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 Names:

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 Names:

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 Names:

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 Names:

MouthKote

Outcome Measures

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. [8-10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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