Cognitive Function After Radiation Therapy for Primary Brain Tumours
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive tests and Patient Reported Outcomes.
- Who it may be relevant to
- Registry conditions: Primary Brain Tumour, Radiation Toxicity, Cognitive Impairment. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.
Detailed description
RT is fundamental in the treatment of primary brain tumours. RT contributes to improved local control and prolonged progression-free survival in patients with a broad range of tumour types. Irradiation to the normal brain may lead to cognitive impairments. Clarifying the nature and severity of impairment in adult RT-treated brain tumour patients, including region-specific effects, are important for optimal utilization of novel conformal RT technologies such as proton therapy.
The study is a prospective nationwide study including approximately 300 brain tumour patients from the Danish Center of Particle Therapy and the four Neuro Oncology Centers in Denmark.
The patients will be assessed with a comprehensive battery of standardized cognitive tests and complete a questionnaire (PRO's). They will do this prior to RT treatment and 1, 3, 5 and 10 years afterwards. The PRO's includes measures on quality of life, fatigue, sleep, depression, anxiety, and socio demographics. The standardized tests are: Trail making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV. The correlation between cognitive scores and RT dose-volume parameters to specific areas in the brain will be tested.
This study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.
Interventions
- Other Cognitive tests and Patient Reported Outcomes
Each patient will undergo cognitive tests and questionnaires
Primary outcome measures
- Impairment of verbal learning and memory as assessed by the HVLT-r test [Time frame: 10 Years]
Secondary outcome measures (12)
- Processing speed I [Time frame: 10 years]
- Processing speed II [Time frame: 10 years]
- Attention and working memory [Time frame: 10 years]
- Verbal learning and memory [Time frame: 10 years]
- Verbal fluency [Time frame: 10 years]
- Executive function I [Time frame: 10 years]
- Executive function II [Time frame: 10 years]
- Global Health - Quality of life [Time frame: 10 years]
- Side effects to radiation therapy [Time frame: 10 years]
- Quality of Sleep [Time frame: 10 years]
- Fatigue [Time frame: 10 years]
- Depression/Anxiety [Time frame: 10 years]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 5 centers
- Department of Oncology, Rigshospitalet — Copenhagen
- Danish Center for Particel Therapy — Aarhus
- Department of Oncology, Aarhus University Hospital — Aarhus
- Department of Oncology, Aalborg University Hospital — Aalborg
- Department of Oncology, Odense University Hospital — Odense
Identifiers
NCT: NCT04306432 · DNOG-2