Comparing Over-the-counter Dry Mouth Remedies After Radiation

University of Oklahoma (OU)

Status and phase: Completed; Phase 1

Conditions: Xerostomia

Treatments: Other: sugar-free chewing gum; Other: chewing gum; Drug: mouth spray; Other: mouth rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT00595933

Dry Mouth_Krempl

IRB # 12518 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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28 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: mouth spray

Other: chewing gum

Other: sugar-free chewing gum

Other: mouth rinse

Drug: mouth spray

Other: mouth rinse