Trial of Parotid Sparing Whole Brain Radiation

NCT03595878 | Completed Results FDA Device

• 1 other identifier: LCCC 1802
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Whole Brain Radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Freedom From Relapse

  Up to 6 months

• Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment

  Up to 45 days

Study Arms (3)

Randomized Arm - Control Group

ACTIVE COMPARATOR

Patients randomized to this group will receive standard WBRT.

Radiation: Standard WBRT

Randomized Arm - Intervention Group

EXPERIMENTAL

Patients randomized to this group will receive parotid sparing WBRT.

Radiation: Parotid sparing WBRT

Observational Arm

NO INTERVENTION

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

Interventions

Parotid sparing WBRT RADIATION

Whole Brain Radiation Therapy with avoidance of the parotid glands

Randomized Arm - Intervention Group

Standard WBRT RADIATION

Standard Whole Brain Radiation Therapy

Randomized Arm - Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• University of North Carolina, Chapel Hill: collaborator
• University of Michigan: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

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

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Colette Shen
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

cjshen@email.unc.edu

+1 984-974-0400

Study Officials

• Colette Shen

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: July 23, 2018
• Study Start: May 9, 2018
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: April 25, 2025
• Results First Posted: April 24, 2023

Record last verified: 2023-03

Locations

US (3)