Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05011045
Collaborator
(none)
50
1
45.7
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Magnetic Resonance Imaging
  • Other: Neurocognitive Assessment
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. Record patients' cognitive outcomes after whole-brain radiation therapy (WBRT) for hematologic malignancies using standard-of-care neurocognitive function testing.
SECONDARY OBJECTIVES:
  1. Assess patients' quality-of-life after WBRT for hematologic malignancies, based on a validated questionnaire.

  2. Explore magnetic resonance imaging (MRI) changes in the brain after WBRT for hematologic malignancies, based on standard-of-care imaging studies.

  3. 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
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
Actual Study Start Date :
Jan 9, 2020
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Undergo MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Other: Neurocognitive Assessment
    Undergo neurocognitive function assessment

    Other: Quality-of-Life Assessment
    Complete questionnaires
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive outcomes [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 Outcome Measures

    1. Quality-of-life [Up to 5 years]

      Assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30/Brain Neoplasm 20. The rates of improvement and worsening will be calculated. The rate of deterioration will be calculated. Also, Wilcoxon signed rank test or paired t-test will be used to compare the scores between baseline and after radiation at 2 months.

    2. Magnetic resonance imaging (MRI) changes [Baseline up to 5 years]

      Will explore radiographic changes on standard-of-care MRI scans that are suggestive of radiation toxicity. Radiographic changes will be considered in the context of radiation treatment plans. Correlation of radiographic changes with radiation dose will be performed for hypothesis generation. Spearman correlation coefficient may be used to assess the correlation between radiographic changes and radiation dose.

    3. Role of medications indicated to improve memory and cognitive function [Up to 5 years]

      Neurocognitive outcomes at different time points will be summarized using descriptive statistics. Changes overtime on neurocognitive outcomes may be analyzed using generalized linear models for the repeated measures. May compare the neurocognitive outcomes of the patients to a similar cohort of patients that were not treated with Memantine or other medications indicated to improve memory and cognitive function (example the RT arm of RTOG 1114). Will amend the protocol to include the details on which cohort of patients to be compared to, variables to be used for matching the two patient cohorts, and method to be used for matching once decided to proceed with the comparison.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Bouthaina S Dabaja, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05011045
    Other Study ID Numbers:
    • PA18-0791
    • NCI-2021-08429
    • PA18-0791
    • P30CA016672
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022