Trial of Parotid Sparing Whole Brain Radiation

  • STATUS
    Recruiting
  • End date
    Nov 27, 2021
  • participants needed
    180
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
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Updated on 27 January 2021
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brain metastases

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.

Details
Condition Xerostomia, Salivary Gland Disease, Saliva and Salivary Gland Dysfunction, Dry Mouth
Treatment Parotid sparing WBRT, Standard WBRT
Clinical Study IdentifierNCT03595878
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on27 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Saliva and Salivary Gland Dysfunction or Dry Mouth or Salivary Gland Disease or Xerostomia?
Do you have any of these conditions: Salivary Gland Disease or Saliva and Salivary Gland Dysfunction or Xerostomia or Dry Mouth?
Do you have any of these conditions: Saliva and Salivary Gland Dysfunction or Salivary Gland Disease or Dry Mouth or Xerostomia?
Do you have any of these conditions: Dry Mouth or Xerostomia or Saliva and Salivary Gland Dysfunction or Salivary Gland Disease?
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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