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Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation (NRR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02682199
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : September 23, 2019
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Patient-Reported Xerostomia After Whole Brain Radiation
Actual Study Start Date : October 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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

Primary Outcome Measures :
  1. Measureable acute increase in xerostomia [ Time Frame: baseline to 1 month post-treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing whole brain radiation treatment at Lineberger Comprehensive cancer Center.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02682199

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United States, North Carolina
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
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Principal Investigator: Kyle Wang, MD University of North Carolina, Chapel Hill

Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT02682199     History of Changes
Other Study ID Numbers: LCCC1540
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases