Clinical trial NCT03595878: Trial of Parotid Sparing Whole Brain Radiation
Official title: Randomized Trial of Parotid Sparing Whole Brain Radiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Keywords: Whole Brain Radiation
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Michigan
name: Wake Forest University Health Sciences
First posted: 2018-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Xerostomia One Month After Completion of Treatment
timeFrame: Up to 45 days
Secondary outcomes:
measure: Freedom From Relapse
timeFrame: Up to 6 months
measure: Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment
timeFrame: Up to 45 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill, Department of Radiation Oncology
name: Colette Shen
role: PRINCIPAL_INVESTIGATOR
References: