Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
NCT ID: NCT05011045
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2020-01-09
2026-10-31
Brief Summary
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Detailed Description
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I. Record patients' cognitive outcomes after whole-brain radiation therapy (WBRT) for hematologic malignancies using standard-of-care neurocognitive function testing.
SECONDARY OBJECTIVES:
I. Assess patients' quality-of-life after WBRT for hematologic malignancies, based on a validated questionnaire.
II. Explore magnetic resonance imaging (MRI) changes in the brain after WBRT for hematologic malignancies, based on standard-of-care imaging studies.
III. Study the role of Memantine in patients' cognitive outcomes during and after WBRT for hematologic malignancies, based on standard-of-care use, utilizing standard-of-care neurocognitive function testing.
OUTLINE:
Patients undergo neurocognitive function assessments, complete questionnaires over 8-10 minutes and undergo standard of care MRI at baseline (within 4 weeks before the first day of WBRT), 2, 6, 12 months after RT completion, then annually for 5 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (neurocognitive assessment, questionnaires, MRI)
Patients undergo neurocognitive function assessments, complete questionnaires over 8-10 minutes and undergo standard of care MRI at baseline (within 4 weeks before the first day of WBRT), 2, 6, 12 months after RT completion, then annually for 5 years.
Magnetic Resonance Imaging
Undergo MRI
Neurocognitive Assessment
Undergo neurocognitive function assessment
Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Interventions
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Magnetic Resonance Imaging
Undergo MRI
Neurocognitive Assessment
Undergo neurocognitive function assessment
Quality-of-Life Assessment
Complete questionnaires
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with radiation therapy to the brain for a hematologic malignancy (ex. primary central nervous system lymphoma \[PCNSL\], secondary central nervous system lymphoma \[SCNSL\], leukemia, myeloma)
* Proficient and capable of completing tests in English
* Patients with claustrophobia are eligible if the claustrophobia is managed with medication
* Patients with cognitively-impairment are eligible if the impairment is managed with medication
* Patients who are pregnant
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Bouthaina S Dabaja
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Dustin M. Silk
Role: primary
Other Identifiers
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PA18-0791
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2021-08429
Identifier Type: OTHER
Identifier Source: secondary_id
PA18-0791
Identifier Type: -
Identifier Source: org_study_id