Comparing Over-the-counter Dry Mouth Remedies After Radia... | NCT00595933

Studies
Comparing Over-the-counter Dry Mouth Remedies After Radiation

NCT00595933

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Sep 7, 2022Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Xerostomia

Interventions

sugar-free chewing gum
chewing gum
mouth rinse
mouth rinse
mouth spray
mouth spray

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB # 12518	Other Identifier	Institutional Review Board

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Jan 2, 2008

First Posted Date

Jan 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2022

Last Update Posted Date

Sep 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	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 Other: chewing gum Other: mouth rinse Drug: mouth spray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	1

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Greg Krempl, MD	University of Oklahoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oklahoma Health Sciences Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D014987	Xerostomia
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002638	Chewing Gum
D009067	Mouthwashes

Ancestor Terms

ID	Term
D053149	Plant Gums
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided