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Trial of Parotid Sparing Whole Brain Radiation

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ClinicalTrials.gov Identifier: NCT03595878
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
UNC Department of Radiation Oncology
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Xerostomia Radiation: Parotid sparing WBRT Radiation: Standard WBRT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Trial of Parotid Sparing Whole Brain Radiation
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Active Comparator: Randomized Arm - Control Group
Patients randomized to this group will receive standard WBRT.
Radiation: Standard WBRT
Standard Whole Brain Radiation Therapy

Experimental: Randomized Arm - Intervention Group
Patients randomized to this group will receive parotid sparing WBRT.
Radiation: Parotid sparing WBRT
Whole Brain Radiation Therapy with avoidance of the parotid glands

No Intervention: Observational Arm
Patients enrolled in this arm will be treated per their treating physician's choice.



Primary Outcome Measures :
  1. Change from Baseline Xerostomia in Randomized Patients Post-Treatment [ Time Frame: Primary time frame of interest is baseline to 1 month post-treatment; study questionnaire administered at baseline, end of treatment (an expected average of about 10 days), and 2 weeks, 1 month, 3 months, & 6 months post-treatment ]
    Proportion of randomized patients experiencing measurable acute increase in xerostomia, per symptoms reported in the study questionnaire, that is clinically significant


Secondary Outcome Measures :
  1. Freedom from Relapse [ Time Frame: Continuously monitored throughout follow-up (an expected average of about 6 months) ]
    Time to marginal relapse and time to upper cervical spine relapse in each randomization arm

  2. Change from Baseline Xerostomia in All Patients Post-Treatment Based on Treatment Fields [ Time Frame: Primary time frame of interest is baseline to 1 month post-treatment; study questionnaire administered at baseline, end of treatment (an expected average of about 10 days), and 2 weeks, 1 month, 3 months, & 6 months post-treatment ]
    Difference in proportion of all patients experiencing measurable acute increase in xerostomia that is clinically significant based on use of standard versus parotid-sparing fields


Other Outcome Measures:
  1. Volume/Dose Relationship [ Time Frame: Primary time frame of interest is baseline to 1 month post-treatment ]
    Association between the degree of change in xerostomia score and the radiation dose received by the parotid glands

  2. Change in Bothersomeness of Xerostomia [ Time Frame: Baseline to post-treatment time points - end of treatment (an expected average of about 10 days) and 2 weeks, 1 month, 3 months, & 6 months post-treatment ]
    Assessment of the change in xerostomia "bother symptoms" on the study questionnaire

  3. Xerostomia Progression Timeline [ Time Frame: Primary time frame of interest is baseline to 6 months post-treatment ]
    Effect of whole brain radiation on the speed of the progression of xerostomia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients to be treated with WBRT using 3-dimensional conformal RT in 10-20 fractions to a total dose of 30-40 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-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595878


Contacts
Contact: Zahra Mahbooba 9849748744 zahra_mahbooba@med.unc.edu
Contact: Emily Goldman 9849748441 emily_goldman@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill, Department of Radiation Oncology Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Emily Goldman    984-974-8441    emily_goldman@med.unc.edu   
Contact: Zahra Mahbooba    9849748744    zahra_mahbooba@med.unc.edu   
Principal Investigator: Kyle Wang         
High Point Regional Health Recruiting
High Point, North Carolina, United States, 27262
Contact: Laura Hayes    336-781-2235    laura.hayes@unchealth.unc.edu   
Principal Investigator: Mohit Kasibhatla         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
UNC Department of Radiation Oncology
Investigators
Principal Investigator: Kyle Wang University of North Carolina at Chapel Hill, Department of Radiation Oncology

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03595878     History of Changes
Other Study ID Numbers: LCCC 1802
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Whole Brain Radiation

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases