Assessing cognitive function in brain tumor patients after radiation therapy
Cognitive Function After Radiation Therapy for Primary Brain Tumours
University of Aarhus · NCT04306432
This study is trying to see how radiation therapy affects thinking skills over time in patients with primary brain tumors, except glioblastoma, by checking their cognitive function at different points after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Drugs / interventions | radiation |
| Locations | 5 sites (Copenhagen, Capital Region and 4 other locations) |
| Trial ID | NCT04306432 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates cognitive function in patients with primary brain tumors who have undergone radiation therapy. It aims to identify the relationship between radiation dose and cognitive impairment by assessing patients at multiple time points: before treatment and at 1, 3, 5, and 10 years post-treatment. A comprehensive battery of standardized cognitive tests and patient-reported outcomes will be utilized to gather data on cognitive performance and quality of life. The study includes various types of brain tumors, excluding glioblastoma, and is conducted across multiple centers in Denmark.
Who should consider this trial
Good fit: Ideal candidates are Danish-speaking adults aged 18 and older with specific types of primary brain tumors, excluding glioblastoma.
Not a fit: Patients with glioblastoma or those with a performance status of 3-4 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cognitive impairments in brain tumor patients receiving radiation therapy.
How similar studies have performed: While studies on cognitive function post-radiation exist, this study's specific focus on dose-response relationships in various brain tumor types is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older and Danish speaking. * Performance status WHO 0-2 * Capable of cooperating on testing * Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas Exclusion Criteria: * Glioblastoma * Performance status 3-4 (Karnofsky Performances of 60 or less)
Where this trial is running
Copenhagen, Capital Region and 4 other locations
- Department of Oncology, Rigshospitalet — Copenhagen, Capital Region, Denmark (RECRUITING)
- Danish Center for Particel Therapy — Aarhus, Region Midt, Denmark (RECRUITING)
- Department of Oncology, Aarhus University Hospital — Aarhus, Region Midt, Denmark (RECRUITING)
- Department of Oncology, Aalborg University Hospital — Aalborg, Region Nord, Denmark (RECRUITING)
- Department of Oncology, Odense University Hospital — Odense, Region Syd, Denmark (RECRUITING)
Study contacts
- Principal investigator: Lene Haldbo-Classen, M.D — Aarhus University Hospital
- Study coordinator: Morten Høyer, MD
- Email: morthoey@rm.dk
- Phone: +45 2328 2823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Brain Tumour, Radiation Toxicity, Cognitive Impairment, Brain tumour, Radiation therapy, Cognitive function, Hippocampus, Patient reported outcomes