XerostomiaNRRNCT02682199
Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
An observational study of Xerostomia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Xerostomia
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 30 Aug 2018
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing whole brain radiation treatment at Lineberger Comprehensive cancer Center.
Who may be able to join
- Patients to be treated with whole brain radiation in 10-15 fractions to a total dose of 25-37.5 Gy for a diagnosis of brain metastases from any disease site or as prophylaxis in the treatment of potentially subclinical intracranial disease (e.g. from small cell lung cancer).
- Has not had prior radiation that would have exposed the parotids to a significant (estimated >10 Gy mean parotid dose) level of radiation within the past one year. Patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated <1 Gy) radiation.
- Greater than or equal to 18 years of age (no upper age limit).
- Informed consent obtained.
Who cannot join
- Patients receiving whole brain radiation without the use of a CT-based planning simulation.
- Patients who are on medications known to cause dry mouth, such as anticholinergics.
- Physically unable to communicate by paper or phone to complete the study survey.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
About this study
Official title: Prospective Evaluation of Patient-Reported Xerostomia After Whole Brain Radiation
The goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.
Read the detailed description
The parotids have not been traditionally considered an organ at risk / avoidance structure in whole brain radiation. However, patients receiving whole brain radiation sometimes complain of dry mouth. Investigators hypothesize that standard whole brain radiation fields cause an acute measurable increase in xerostomia at one month post-radiation, and that the severity of xerostomia is related to the dose received by the parotids. In this study, investigators will use the validated University of Michigan Xerostomia Questionnaire to prospectively collect baseline and post-radiation xerostomia scores up to 6 months after treatment. The radiation dose to the parotids will be evaluated to assess whether there is a dose-toxicity relationship. Investigators anticipate a total accrual of 60 patients with a goal of 48 evaluable patients.
- Conditions
- Xerostomia
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Whole Brain Radiation | Patients scheduled to receive whole brain radiation with or without chemotherapy/targeted therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measureable acute increase in xerostomia
Measured: baseline to 1 month post-treatment
Secondary outcomes (2)
Association of degree of change in xerostomia score and the radiation dose received by the parotid glands
Measured: baseline to 1 month post-RT
Effect of whole brain radiation on the time course of xerostomia
Measured: baseline and four post-radiation time points (procedure, 1 month post-RT, 3 months post-RT, 6 months post-RT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2018
- Study completion30 Aug 2018
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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Wang, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682199
- Sponsor's protocol ID
- LCCC1540
- Acronym
- NRR
- Status last verified
- Sep 2019
- First submitted
- 20 Jan 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Patient-Reported Xerostomia After Whole Brain Radiation
- ClinicalTrials.gov ID
- NCT02682199
- Acronym / sponsor ID
- NRR / LCCC1540
- Conditions
- Xerostomia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 15 Feb 2016 (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 goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.
Detailed description
The parotids have not been traditionally considered an organ at risk / avoidance structure in whole brain radiation. However, patients receiving whole brain radiation sometimes complain of dry mouth. Investigators hypothesize that standard whole brain radiation fields cause an acute measurable increase in xerostomia at one month post-radiation, and that the severity of xerostomia is related to the dose received by the parotids. In this study, investigators will use the validated University of Michigan Xerostomia Questionnaire to prospectively collect baseline and post-radiation xerostomia scores up to 6 months after treatment. The radiation dose to the parotids will be evaluated to assess whether there is a dose-toxicity relationship. Investigators anticipate a total accrual of 60 patients with a goal of 48 evaluable patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Brain Radiation | – | –Patients scheduled to receive whole brain radiation with or without chemotherapy/targeted therapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing whole brain radiation treatment at Lineberger Comprehensive cancer Center.
Key inclusion criteria (4 listed)
- Patients to be treated with whole brain radiation in 10-15 fractions to a total dose of 25-37.5 Gy for a diagnosis of brain metastases from any disease site or as prophylaxis in the treatment of potentially subclinical intracranial disease (e.g. from small cell lung cancer).
- Has not had prior radiation that would have exposed the parotids to a significant (estimated >10 Gy mean parotid dose) level of radiation within the past one year. Patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated <1 Gy) radiation.
- Greater than or equal to 18 years of age (no upper age limit).
- Informed consent obtained.
Key exclusion criteria (4 listed)
- Patients receiving whole brain radiation without the use of a CT-based planning simulation.
- Patients who are on medications known to cause dry mouth, such as anticholinergics.
- Physically unable to communicate by paper or phone to complete the study survey.
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measureable acute increase in xerostomia
Time frame: baseline to 1 month post-treatment
2 secondary outcomes
Association of degree of change in xerostomia score and the radiation dose received by the parotid glands
Time frame: baseline to 1 month post-RT
Effect of whole brain radiation on the time course of xerostomia
Time frame: baseline and four post-radiation time points (procedure, 1 month post-RT, 3 months post-RT, 6 months post-RT).
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 23 Sep 2019.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
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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.
Kyle Wang, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerostomia, run by UNC Lineberger Comprehensive Cancer Center 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 4 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 23 Sep 2019. 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.
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?
Measureable acute increase in xerostomia (time frame: baseline to 1 month post-treatment). 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 23 Sep 2019.