Cognitive Function After Treatment of Primary CNS Malignancy

Completed

• Conditions: CNS Malignancy

• Registration Number: NCT03055364
• Lead Sponsor: Mayo Clinic

Brief Summary

In this study, the investigators propose to evaluate cognitive function and determine the feasibility of neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent. The investigators will use the CogState software to quantify changes in verbal learning, memory, and executive function over the initial months and years following radiation treatment. Cognitive changes and temporal patterns of function will be compared to baseline performance for each patient. Data regarding cognitive function, fatigue, quality of life, and standard patient reported outcomes will be collected to characterize the daily impact of treatment. In addition, observed outcomes will be correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-16
• Study Start: 2017-06-13
• Primary Completion: 2023-11-02
• Study Completion: 2023-11-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Age ≥ 4 years with primary CNS malignancy
• Able to use computer for assessment battery
• Receiving photon- or proton-based radiation for primary intracranial malignancy
• Demonstrates the capacity to sign informed consent

Exclusion Criteria

• Patients with WHO Grade IV tumors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
characterize the rate and magnitude of change in cognitive performance within 12 months of completion of therapy in patients with intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent	baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy	Using the CogState software

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States