Cognitive Function After Treatment of Primary CNS Malignancy

Observational Study Evaluating Neurocognitive Function in Patients With Primary CNS Malignancy Receiving Radiation Treatment to the Brain

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03055364

Enrollment

129

Registered

2017-02-16

Start date

2017-06-13

Completion date

2023-11-02

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CNS Malignancy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results