Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 99
Updated:9/2/2018
Start Date:October 2015
End Date:August 30, 2018

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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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: Kyle Wang, MD
Phone: 984-974-8635
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mi
from
Chapel Hill, NC
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