Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients with radiation therapy to the brain for a hematologic malignancies

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Neurocognitive Assessment

    Other intervention

    Undergo neurocognitive function assessment

  • Quality-of-Life Assessment

    Other intervention

    Complete questionnaires

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Observational (neurocognitive assessment, questionnaires, MRI)4 interventions

Trial outcomes

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.

Time frame
Up to 5 years

Secondary outcomes

1

Quality-of-life

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.

Time frame
Up to 5 years
2

Magnetic resonance imaging (MRI) changes

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.

Time frame
Baseline up to 5 years
3

Role of medications indicated to improve memory and cognitive function

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.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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