Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Plasma Cell Myeloma; Hematopoietic and Lymphoid Cell Neoplasm; Lymphoma; Central Nervous System Lymphoma; Leukemia; Secondary Central Nervous System Lymphoma

Treatments: Other: Neurocognitive Assessment; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Procedure: Magnetic Resonance Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05011045

PA18-0791 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

100 participants in 1 patient group

Observational (neurocognitive assessment, questionnaires, MRI)

Description:

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.

Treatment:

Procedure: Magnetic Resonance Imaging

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Neurocognitive Assessment