XerostomiaPhase 1NCT00595933
Comparing Over-the-counter Dry Mouth Remedies After Radiation
A Phase 1 study testing sugar-free chewing gum, chewing gum and mouth rinse in people with Xerostomia, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerostomia
- What is being tested?
- sugar-free chewing gum, chewing gum and mouth rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently using the following medications: anorexiants, antiacne agents, Anticholinergic agents, tricyclic antidepressants, chemotherapy agents.
- Unable to complete questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck
The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.
Read the 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.
- Conditions
- Xerostomia
- Being tested
- sugar-free chewing gum, chewing gum, mouth rinse, mouth spray
- Keywords
- Head and Neck cancer, Radiation therapy, Dry mouth remedies, Dry Mouth, Xerostomia
- Medical subject headings
- Xerostomia, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugar-free chewing gumOther
Also called Freedent chewing gum
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
chewing gumOther
Also called Biotene chewing gum
Chew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
mouth rinseOther
Also called Flavored water
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire
mouth rinseOther
Also called Biotene mouth rinse
Rinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week.
mouth sprayDrug
Also called Salivart
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 sprayDrug
Also called MouthKote
Spray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: sugar-free chewing gum; Other: chewing gum; Other: mouth rinse; Drug: mouth spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of seven over-the-counter remedies for dry mouth as determined by amount of saliva output and a brief questionaire.
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startMar 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greg Krempl, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595933
- Sponsor's protocol ID
- Dry Mouth_Krempl
- Other IDs
- IRB # 12518
- Status last verified
- Sep 2022
- First submitted
- 20 Dec 2007
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial of Over-the-counter Dry Mouth Remedies for Dry Mouth After Radiation to the Head and Neck
- ClinicalTrials.gov ID
- NCT00595933
- Acronym / sponsor ID
- Dry Mouth_Krempl
- Conditions
- Xerostomia
- Keywords
- Head and Neck cancer, Radiation therapy, Dry mouth remedies, Dry Mouth, Xerostomia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: sugar-free chewing gum, Other: chewing gum, Other: mouth rinse, Drug: mouth sprayEach 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Currently using the following medications: anorexiants, antiacne agents, Anticholinergic agents, tricyclic antidepressants, chemotherapy agents.
- Unable to complete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sugar-free chewing gumAlso: Freedent chewing gumChew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week. | Other | 1 |
| chewing gumAlso: Biotene chewing gumChew gum 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week. | Other | 1 |
| mouth rinseAlso: Flavored waterRinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week questionaire | Other | 1 |
| mouth rinseAlso: Biotene mouth rinseRinse mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week. | Other | 1 |
| mouth sprayAlso: SalivartSpray mouth with mouth spray 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week | Drug | 1 |
| mouth sprayAlso: MouthKoteSpray mouth 4 times a day with additional allowances for as needed. Fill out daily questionaire and an end of week | Drug | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Krempl, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sugar-free chewing gum, chewing gum and mouth rinse in people with Xerostomia, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.