Trial of Parotid Sparing Whole Brain Radiation

NCT ID: NCT03595878

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2022-03-16

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.

Conditions

Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Randomized Arm - Control Group

Patients randomized to this group will receive standard WBRT.

Group Type: ACTIVE_COMPARATOR

Standard WBRT

Intervention Type: RADIATION

Standard Whole Brain Radiation Therapy

Randomized Arm - Intervention Group

Patients randomized to this group will receive parotid sparing WBRT.

Group Type: EXPERIMENTAL

Parotid sparing WBRT

Intervention Type: RADIATION

Whole Brain Radiation Therapy with avoidance of the parotid glands

Observational Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Parotid sparing WBRT

Whole Brain Radiation Therapy with avoidance of the parotid glands

Intervention Type: RADIATION

Standard WBRT

Standard Whole Brain Radiation Therapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colette Shen

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LCCC 1802

Identifier Type: -

Identifier Source: org_study_id