Cerebral Morbidity After Radiation Therapy for Brain Tumors

  • STATUS
    Recruiting
  • participants needed
    67
  • sponsor
    University of Aarhus
Updated on 19 February 2024
sarcoma
pituitary
cognitive impairment
brain tumor
glioblastoma multiforme
astrocytoma
anaplastic astrocytoma
medulloblastoma
meningioma
glioblastoma
cognitive dysfunction
sarcomas
pituitary adenoma

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.

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 , 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.

Details
Condition Malignant neoplasm of brain, Cognitive Impairment, Radiation Toxicity
Age 18years - 100years
Treatment Cognitive tests and Patient Reported Outcome
Clinical Study IdentifierNCT04292353
SponsorUniversity of Aarhus
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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