Skip to main content
OpenTrials
Completed

NCT Number: NCT00595933

Comparing Over-the-counter Dry Mouth Remedies After Radiation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Xerostomia Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sugar-free chewing gum

Other

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

Chewing Gum

Other

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

mouth rinse

Other

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

mouth spray

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jan 16, 2008
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.