Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies

Lymphoma Clinical Trial

Official title:

Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05011045
• Other study ID #: PA18-0791
• Secondary ID: NCI-2021-08429PA
• Status: Recruiting
• Start date: January 9, 2020
• Est. completion date: October 31, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm
• Leukemia
• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma
• Secondary Central Nervous System Lymphoma

Intervention

Procedure:
• Magnetic Resonance Imaging
Undergo MRI

Other:
• Neurocognitive Assessment
Undergo neurocognitive function assessment
• Quality-of-Life Assessment
Complete questionnaires
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 5 years
Secondary	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.	Baseline up to 5 years
Secondary	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.	Up to 5 years