Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-08-30

Brief Summary

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The goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.

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Detailed Description

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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

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Xerostomia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Whole Brain Radiation

Patients scheduled to receive whole brain radiation with or without chemotherapy/targeted therapy.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No