Trial of Parotid Sparing Whole Brain Radiation
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/21/2018 |
| Start Date: | May 9, 2018 |
| End Date: | November 2021 |
| Contact: | Zahra Mahbooba |
| Email: | zahra_mahbooba@med.unc.edu |
| Phone: | 9849748744 |
Randomized Trial of Parotid Sparing Whole Brain Radiation
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.
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.
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.
We found this trial at
2
sites
Chapel Hill, North Carolina 27599
Principal Investigator: Kyle Wang
Phone: 984-974-8441
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High Point, North Carolina 27262
Principal Investigator: Mohit Kasibhatla
Phone: 336-781-2235
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