Comparing Over-the-counter Dry Mouth Remedies After Radiation

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00595933

Enrollment

Registered

2008-01-16

Start date

2005-03-31

Completion date

2010-06-30

Last updated

2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia

Keywords

Head and Neck cancer, Radiation therapy, Dry mouth remedies, Dry Mouth, Xerostomia

Brief summary

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

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.

Interventions

OTHERsugar-free chewing gum

Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.

OTHERchewing gum

Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.

OTHERmouth rinse

Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire

DRUGmouth 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026