Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies

NCT05011045 | Recruiting

• 2 other identifiers: PA18-0791NCI-2021-08429
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cognitive outcomes

  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.

  Up to 5 years

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

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

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Observational (neurocognitive assessment, questionnaires, MRI)

Neurocognitive Assessment OTHER

Undergo neurocognitive function assessment

Observational (neurocognitive assessment, questionnaires, MRI)

Quality-of-Life Assessment OTHER

Complete questionnaires

Also known as: Quality of Life Assessment

Observational (neurocognitive assessment, questionnaires, MRI)

Questionnaire Administration OTHER

Complete questionnaires

Observational (neurocognitive assessment, questionnaires, MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with radiation therapy to the brain for a hematologic malignancies

You may qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Multiple Myeloma

Interventions

Magnetic Resonance Spectroscopy; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Bouthaina S Dabaja

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dustin M Silk

CONTACT

713-563-3090; dmdmsilk@mdanderson.orgsilk@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 18, 2021
• Study Start: January 9, 2020
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)