Cerebral Morbidity After Radiation Therapy for Brain Tumors

University of Aarhus67 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Brain Tumor Cognitive Impairment Radiation Toxicity

Interventions

Cognitive tests and Patient Reported OutcomeOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Rigshospital

Copenhagen, Region H, Denmark

Department of Oncology

Aarhus, Region Midt, Denmark

Aalborg University Hospital

Aalborg, Region Nord, Denmark

Odense University Hospital

Odense, Region Syd, Denmark

Outcomes

Primary Outcomes

Impairment of memory as assessed by the HVLT-r test

Examined by the Hopkins Verbal Learning Test. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)

Time frame: 5 Years

Secondary Outcomes

Processing speed

Examined by the Trail making Test part A (TMT\_A) and the Coding from WAIS-IV. Outcome for TMT\_A is time in seconds (0-120 seconds). Outcome for Coding is number of correct (within 2 minutes) (0-100)

Time frame: 5 Years

Attention and working memory

Examined by WAIS\_IV\_digit\_span and PASAT (Pased Auditory Seriel Addition Test). Outcome on WAIS digit span is number of correct (0-36) and outcome for PASAT is number of incorrects (0-60)

Time frame: 5 Years

Verbal learning and memory

Examine by the Hopkins Verbal Learning Test (HVLT) - total and delayed. Outcome is number of correct words (0-24)

Time frame: 5 Years

Verbal fluency

Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter\_S. Outcome is number of words produced in 1 minute (0-100)

Time frame: 5 Years

Executive function

Examined by Trail making Test part B (TMT-B) and the STROOP colour and word test (STROOP). Outcome for TMT\_B is time in seconds (0-300). Outcome for STROOP is number of corrects (0-120)

Time frame: 5 Years

Global Health - Quality of life

Assessed by questionnaire; EORTC QlQ-C30 in order to examine the level of quality of life in brain tumour patients who has received radiation therapy. Quality of life will be assessed by EORTC QIQ-C-30

Data from ClinicalTrials.gov

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