Comparing Over-the-counter Dry Mouth Remedies After Radiation

NCT ID: NCT00595933

Last Updated: 2022-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

sugar-free chewing gum

Intervention Type OTHER

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

chewing gum

Intervention Type OTHER

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

mouth rinse

Intervention Type OTHER

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

mouth rinse

Intervention Type OTHER

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

mouth spray

Intervention Type 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

mouth spray

Intervention Type DRUG

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

Interventions

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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.

Intervention Type OTHER

chewing gum

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

Intervention Type 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

Intervention Type OTHER

mouth rinse

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

Intervention Type 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

Intervention Type DRUG

mouth spray

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

Intervention Type DRUG

Other Intervention Names

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Freedent chewing gum Biotene chewing gum Flavored water Biotene mouth rinse Salivart MouthKote

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greg Krempl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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IRB # 12518

Identifier Type: OTHER

Identifier Source: secondary_id

Dry Mouth_Krempl

Identifier Type: -

Identifier Source: org_study_id

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