Actively Recruiting
Cognitive Function After Radiation Therapy for Primary Brain Tumours
Led by University of Aarhus · Updated on 2021-12-02
300
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating cognitive function in adults with various primary brain tumours, excluding glioblastoma, who are treated with radiation therapy (RT). The study aims to understand how RT affects cognitive abilities over time and to develop parameters related to radiation sensitivity and brain volume effects that contribute to cognitive dysfunction. This prospective nationwide study includes about 300 patients from specialized centers in Denmark. Participants will undergo a series of standardized cognitive tests and complete questionnaires before starting RT and again at 1, 3, 5, and 10 years after treatment. The tests assess functions such as verbal learning and memory, attention, processing speed, and executive function. The questionnaires measure quality of life, fatigue, sleep quality, depression, anxiety, and socio-demographic factors. Researchers will examine how cognitive test results relate to radiation dose levels received by specific brain regions. Throughout the study, patients will be closely monitored with these cognitive assessments and patient-reported outcomes to track changes over time. The primary outcome is the impairment of verbal learning and memory after 10 years, evaluated by the HVLT-r test. Secondary outcomes include various cognitive functions, quality of life measures, and side effects related to radiation therapy. This long-term follow-up will help identify brain areas most affected by radiation and guide future treatment planning.
CONDITIONS
Brief Title
Cognitive Function After Radiation Therapy for Primary Brain Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older and Danish speaking
- Performance status WHO 0-2
- Capable of cooperating on testing
- Diagnosis of specific primary brain tumours excluding glioblastoma, including anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, and other brain tumours including skull base sarcomas
You will not qualify if you...
- Diagnosis of glioblastoma
- Performance status 3-4 (Karnofsky Performance Score 60 or less)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before treatment
Participants complete baseline cognitive tests and questionnaires prior to radiation therapy.
1 visit (in-person)
Duration - 10 years
Participants complete cognitive tests and questionnaires at several time points after radiation therapy to assess cognitive function and quality of life.
5 visits at 1, 3, 5, and 10 years post-treatment
Trial Site Locations
Total: 5 locations
1
Department of Oncology, Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
2
Danish Center for Particel Therapy
Aarhus, Region Midt, Denmark, 8200
Actively Recruiting
3
Department of Oncology, Aarhus University Hospital
Aarhus, Region Midt, Denmark, 8200
Actively Recruiting
4
Department of Oncology, Aalborg University Hospital
Aalborg, Region Nord, Denmark, 9000
Actively Recruiting
5
Department of Oncology, Odense University Hospital
Odense, Region Syd, Denmark, 5000
Actively Recruiting
Research Team
M
Morten Høyer, MD
L
Lene Haldbo-Classen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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