Clinical trial NCT04306432: Cognitive Function After Radiation Therapy for Primary Brain Tumours
Official title: Cognitive Function After Radiation Therapy for Primary Brain Tumours
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Brain Tumour
Radiation Toxicity
Cognitive Impairment
Keywords: Brain tumour
Radiation therapy
Cognitive function
Hippocampus
Patient reported outcomes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be diagnosed with a primary brain tumour and referred to radiation therapy.

Brief summary: 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.

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)

Primary outcomes:
measure: Impairment of verbal learning and memory as assessed by the HVLT-r test
timeFrame: 10 Years
Secondary outcomes:
measure: Processing speed I
timeFrame: 10 years
measure: Processing speed II
timeFrame: 10 years
measure: Attention and working memory
timeFrame: 10 years
measure: Verbal learning and memory
timeFrame: 10 years
measure: Verbal fluency
timeFrame: 10 years
measure: Executive function I
timeFrame: 10 years
measure: Executive function II
timeFrame: 10 years
measure: Global Health - Quality of life
timeFrame: 10 years
measure: Side effects to radiation therapy
timeFrame: 10 years
measure: Quality of Sleep
timeFrame: 10 years
measure: Fatigue
timeFrame: 10 years
measure: Depression/Anxiety
timeFrame: 10 years
measure: Patient's Assessment of Own Functioning
timeFrame: 10 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
state: Region Hovedstaden
city: Aarhus
country: Denmark
facility: Danish Center for Particel Therapy
state: Region Midt
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
state: Region Midt
city: Aalborg
country: Denmark
facility: Department of Oncology, Aalborg University Hospital
state: Region Nord
city: Odense
country: Denmark
facility: Department of Oncology, Odense University Hospital
state: Region Syd
Study officials:
affiliation: Aarhus University Hospital
name: Lene Haldbo-Classen, M.D
role: PRINCIPAL_INVESTIGATOR
References: