Clinical trial NCT04292353: Cerebral Morbidity After Radiation Therapy for Brain Tumors
Official title: Cerebral Morbidity After Radiation Therapy for Brain Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumor
Cognitive Impairment
Radiation Toxicity
Keywords: Brain tumor
Cognitive function
Radiation Therapy
Hippocampus
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 67
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. They will be recruited from the four neuro oncology centers in Denmark

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 to brain tumours causes cognitive dysfunction. The extent of RT induced changes in cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive dysfunction. There is modest knowledge on which parts of the brain we need to spare, to prevent cognitive dysfunction.

The study is a prospective nationwide study including approximately 60 brain tumour patients from the four neuro oncology centres in Denmark. The patients will do patient reported outcome (PRO) and undergo neuropsychological assessment with standardized tests: They will do this prior to RT treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on quality of life, fatigue, sleep, depression, anxiety, and socio demografica. 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; Paced Auditory Serial Addition Test (PASAT). 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
* Tumor histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas

Exclusion Criteria:

* Glioblastoma
* Performance status 3-4

Primary outcomes:
measure: Impairment of memory as assessed by the HVLT-r test
timeFrame: 5 Years
Secondary outcomes:
measure: Processing speed
timeFrame: 5 Years
measure: Attention and working memory
timeFrame: 5 Years
measure: Verbal learning and memory
timeFrame: 5 Years
measure: Verbal fluency
timeFrame: 5 Years
measure: Executive function
timeFrame: 5 Years
measure: Global Health - Quality of life
timeFrame: 5 Years
measure: Fatigue
timeFrame: 5 years
measure: Qulity of Sleep
timeFrame: 5 years
measure: Depression/Anxiety
timeFrame: 5 years
measure: Patient's Assessment of Own Functioning Inventory
timeFrame: 5 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospital
state: Region H
city: Aarhus
country: Denmark
facility: Department of Oncology
state: Region Midt
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Nord
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Syd
Study officials:
affiliation: Danish Center for Particel Therapy, Aarhus University Hospital, Denmark
name: Morten Høyer, M.D
role: PRINCIPAL_INVESTIGATOR
References: