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Completed

NCT Number: NCT02682199

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measureable acute increase in xerostomia

    Time frame: baseline to 1 month post-treatment

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

Prospective Evaluation of Patient-Reported Xerostomia After Whole Brain Radiation

Acronym: NRR

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2016
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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