Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cognitive outcomes
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cognitive outcomes
Time Frame: Up to 5 years
Neurocognitive failure will be defined as the first cognitive failure on 2 or more of the following tests: the Hopkins Verbal Learning Test Revised Total Recall, Delayed Recall and Delayed Recognition; the Controlled Oral Word Association; and the Trail Making Test Part A or B. The rate of neurocognitive failure and its 95% confidence interval (CI) will be calculated. The cumulative incidence approach may be used to estimate the median time to neurocognitive failure to account for the competing risk of death. May use the Aalen-Johansen estimator of the cumulative incidence function.
Secondary Outcomes
- Quality-of-life(Up to 5 years)
- Magnetic resonance imaging (MRI) changes(Baseline up to 5 years)
- Role of medications indicated to improve memory and cognitive function(Up to 5 years)