Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation

Xerostomia Clinical Trial

— NRR  

Official title:

Prospective Evaluation of Patient-Reported Xerostomia After Whole Brain Radiation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682199
• Other study ID #: LCCC1540
• Status: Completed
• Start date: October 2015
• Est. completion date: August 30, 2018

Study information

• Verified date: September 2019
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Xerostomia

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measureable acute increase in xerostomia		baseline to 1 month post-treatment
Secondary	Association of degree of change in xerostomia score and the radiation dose received by the parotid glands		baseline to 1 month post-RT
Secondary	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).

External Links

•   UNC Lineberger Comprehensive Cancer Center