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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
Whole Brain Radiation Therapy with avoidance of the parotid glands
Standard Whole Brain Radiation Therapy
University of Michigan
Ann Arbor, Michigan, United States
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
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.
Time frame: Up to 45 days
Freedom From Relapse
The number of subjects with marginal cervical spine relapse in each randomization arm.
Time frame: 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.
Time frame: Up to 45 days
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