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

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill, Department of Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing whole brain radiation treatment at Lineberger Comprehensive cancer Center.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measureable acute increase in xerostomia	baseline to 1 month post-treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Association of degree of change in xerostomia score and the radiation dose received by the parotid glands	baseline to 1 month post-RT
Effect of whole brain radiation on the time course of xerostomia	baseline and four post-radiation time points (procedure, 1 month post-RT, 3 months post-RT, 6 months post-RT).

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Kyle Wang, MD, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: LCCC1540