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Trial of Parotid Sparing Whole Brain Radiation

NCT03595878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-25

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of parotid sparing in reducing measurable xerostomia (dry mouth) in patients undergoing whole brain radiotherapy. This is primarily a two-arm, single-blind, randomized study of parotid sparing whole brain radiation therapy (WBRT), with a third observational arm of patients who were identified after radiation had already started or who refused randomization but were willing to be followed for quality of life assessment. Qualifying patients who are interested in participating in the trial will be asked to complete an anonymous screening baseline xerostomia questionnaire. If their raw score on this questionnaire meets eligibility criteria, they will be offered enrollment on the study. Patients identified prior to radiation start will be offered enrollment into the interventional randomization arm, with the observation arm offered to those who refuse randomization. Patients identified after radiation has already started, but within 5 days of the first day of radiation, will be offered enrollment into the observational arm. Questionnaires completed by patients who consent to the trial will be assigned patient information (de-anonymized) and serve as their baseline quality of life data. After baseline assessment, subjects will be asked to complete the same questionnaire again at the end of treatment, as well as two weeks, one month, three months, and six months after treatment completion.

Conditions

  • Xerostomia

Interventions

RADIATION

Parotid sparing WBRT

Whole Brain Radiation Therapy with avoidance of the parotid glands

RADIATION

Standard WBRT

Standard Whole Brain Radiation Therapy

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Colette Shen · University of North Carolina at Chapel Hill, Department of Radiation Oncology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2022-03-16
Completion
2022-03-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595878 on ClinicalTrials.gov