Cognitive Function After Treatment of Primary CNS Malignancy

CNS Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055364
• Other study ID #: 16-005982
• Secondary ID: NCI-2024-00947
• Status: Completed
• Start date: June 13, 2017
• Est. completion date: November 2, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• CNS Malignancy
• Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Using the CogState software	baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy