Trial of Parotid Sparing Whole Brain Radiation

Randomized Trial of Parotid Sparing Whole Brain Radiation

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia
• Intervention / Treatment: Radiation: Standard WBRT; Radiation: Parotid sparing WBRT

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill, Department of Radiation Oncology
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients to be treated with WBRT using 3-dimensional conformal RT in 10-15 fractions to a total dose of 30-35 Gy for any diagnosis other than elective treatment of potentially subclinical intracranial disease.

• No prior radiation that would have exposed the parotids to a significant level of radiation (estimated >10 Gy mean parotid dose). 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.

  • Patients enrolling on the observational arm may have started their current course of whole brain radiation therapy within 5 days prior to completing the baseline screening questionnaire and consenting to study.
• Greater than or equal to 18 years of age (no upper age limit).
• Raw xerostomia score < 40 / 80 on the initial screening xerostomia questionnaire. This is calculated by adding up the values from questions 1-8.
• Initial xerostomia questionnaire and informed consent obtained within the required time frame (≤ 30 days before RT start for interventional arm; ≤ 5 days after RT start for observational arm).

Exclusion Criteria:

• Patients receiving WBRT without the use of a CT- or MRI-based planning simulation.
• Patients receiving WBRT with the use of intensity-modulated radiation therapy.
• Patient receiving WBRT as elective treatment of potentially subclinical intracranial disease (e.g., WBRT for prophylactic cranial irradiation of small cell lung cancer).
• Patients physically unable to communicate by paper or phone to complete the study survey.
• Prisoners.
• Pregnant patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Randomized Arm - Control Group; Patients randomized to this group will receive standard WBRT.	Radiation: Standard WBRT; Standard Whole Brain Radiation Therapy
Experimental: Randomized Arm - Intervention Group; Patients randomized to this group will receive parotid sparing WBRT.	Radiation: Parotid sparing WBRT; Whole Brain Radiation Therapy with avoidance of the parotid glands
No Intervention: Observational Arm; Patients enrolled in this arm will be treated per their treating physician's choice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xerostomia One Month After Completion of Treatment	Between baseline and 1 month after the treatment xerostomia symptoms were assessed, in 2 randomized groups namely Arm A and Arm B. Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes in xerostomia symptoms in each arm were tabulated. Positive values represent increased xerostomia symptoms and negative values represent decreasing xerostomia symptoms and no difference is no change.	Up to 45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From Relapse	The number of subjects with marginal cervical spine relapse in each randomization arm.	Up to 6 months
Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment	Between baseline and 1 month after the treatment xerostomia symptoms were assessed and tabulated based on the whole brain radiotherapy (WBRT) technique. The Standard WBRT Group includes both randomized (Group A) and non-randomized (Group C) subjects who received WBRT. The Parotid Sparing WBRT Group includes subjects who were randomized and received Parotid Sparing WBRT (Group B). Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes were tabulated as: Positive values represent worsened xerostomia symptoms, and both negative values and no change values represent did not worsen.	Up to 45 days

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: University of Michigan; Wake Forest University Health Sciences; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Colette Shen, University of North Carolina at Chapel Hill, Department of Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2018
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Whole Brain Radiation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: LCCC 1802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes