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Trial of Parotid Sparing Whole Brain Radiation

Primary Purpose

Xerostomia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parotid sparing WBRT
Standard WBRT
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Xerostomia focused on measuring Whole Brain Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan
  • University of North Carolina at Chapel Hill, Department of Radiation Oncology
  • Wake Forest Baptist Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Randomized Arm - Control Group

Randomized Arm - Intervention Group

Observational Arm

Arm Description

Patients randomized to this group will receive standard WBRT.

Patients randomized to this group will receive parotid sparing WBRT.

Patients enrolled in this arm will be treated per their treating physician's choice.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Freedom From Relapse
The number of subjects with marginal cervical spine relapse in each randomization arm.
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.

Full Information

First Posted
May 18, 2018
Last Updated
March 31, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
University of North Carolina, Chapel Hill, University of Michigan, Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03595878
Brief Title
Trial of Parotid Sparing Whole Brain Radiation
Official Title
Randomized Trial of Parotid Sparing Whole Brain Radiation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
University of North Carolina, Chapel Hill, University of Michigan, Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
Whole Brain Radiation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Arm - Control Group
Arm Type
Active Comparator
Arm Description
Patients randomized to this group will receive standard WBRT.
Arm Title
Randomized Arm - Intervention Group
Arm Type
Experimental
Arm Description
Patients randomized to this group will receive parotid sparing WBRT.
Arm Title
Observational Arm
Arm Type
No Intervention
Arm Description
Patients enrolled in this arm will be treated per their treating physician's choice.
Intervention Type
Radiation
Intervention Name(s)
Parotid sparing WBRT
Intervention Description
Whole Brain Radiation Therapy with avoidance of the parotid glands
Intervention Type
Radiation
Intervention Name(s)
Standard WBRT
Intervention Description
Standard Whole Brain Radiation Therapy
Primary Outcome Measure Information:
Title
Xerostomia One Month After Completion of Treatment
Description
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.
Time Frame
Up to 45 days
Secondary Outcome Measure Information:
Title
Freedom From Relapse
Description
The number of subjects with marginal cervical spine relapse in each randomization arm.
Time Frame
Up to 6 months
Title
Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment
Description
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.
Time Frame
Up to 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colette Shen
Organizational Affiliation
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of North Carolina at Chapel Hill, Department of Radiation Oncology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest Baptist Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Trial of Parotid Sparing Whole Brain Radiation

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