Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Imaging, Neurocognitive Assessment, Quality-of-Life Assessment, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Central Nervous System Lymphoma, Hematopoietic and Lymphoid Cell Neoplasm, Leukemia, Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). This may help researchers learn more about the effects of whole brain radiation therapy on memory and thinking in patients with blood cancer.
Detailed description
PRIMARY OBJECTIVE:
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.
Interventions
- Procedure Magnetic Resonance Imaging
Undergo MRI - Other Neurocognitive Assessment
Undergo neurocognitive function assessment - Other Quality-of-Life Assessment
Complete questionnaires - Other Questionnaire Administration
Complete questionnaires
Primary outcome measures
- Cognitive outcomes [Time frame: Up to 5 years]
Secondary outcome measures (3)
- Quality-of-life [Time frame: Up to 5 years]
- Magnetic resonance imaging (MRI) changes [Time frame: Baseline up to 5 years]
- Role of medications indicated to improve memory and cognitive function [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05011045 · PA18-0791 · PA18-0791 · NCI-2021-08429