Clinical trial NCT05011045: Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
Official title: Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System Lymphoma
Hematopoietic and Lymphoid Cell Neoplasm
Leukemia
Lymphoma
Plasma Cell Myeloma
Secondary Central Nervous System Lymphoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with radiation therapy to the brain for a hematologic malignancies

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.

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

Primary outcomes:
measure: Cognitive outcomes
timeFrame: Up to 5 years
Secondary outcomes:
measure: Quality-of-life
timeFrame: Up to 5 years
measure: Magnetic resonance imaging (MRI) changes
timeFrame: Baseline up to 5 years
measure: Role of medications indicated to improve memory and cognitive function
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Bouthaina S Dabaja
role: PRINCIPAL_INVESTIGATOR
References: