Clinical trial NCT04118426: Cognitive Function After Radiation Therapy for Brain Tumours
Official title: Cognitive Function After Radiation Therapy for Brain Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Brain Tumor
Radiation Toxicity
Keywords: Cognitive function
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a primary brain tumour grade I-III

Brief summary: This study will assess cognitive function in adult patients with a primary brain tumour treated with surgical resection with or without radiation therapy (RT). 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 the investigators need to spare, to prevent cognitive dysfunction.

The study is a cross sectional study assessing cognitive function in patients with brain tumours previously treated with RT compared to a similar non irradiated group. 104 patients with specified brain tumours from Aarhus University Hospital treated in the period 2006-2016 will be included. 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.

Eligibility criteria: Inclusion Criteria:

* The participant must be 18 years or older and Danish speaking.
* Performance status 0-2
* Capable of cooperating on testing
* Diagnosed with one of the following diagnoses according to WHO 2016 classification 16 and been treated between 2006 and 2016

  1. ZM93803 glioma (exclusive glioblastoma)
  2. ZM9401/3 anaplastic astrocytoma, IDH mutant
  3. ZM9400/3 diffuse astrocytoma, IDH-mutant
  4. ZM9411/3 gemistocytisk astrocytoma, IDH mutant
  5. ZM9400/3 diffuse astrocytoma, NOS
  6. ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted
  7. ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted
  8. ZM9450/3 oligodendroglioma, NOS
  9. ZM9451/3 anaplastic oligodendroglioma, NOS
  10. ZM9530/0 meningioma
  11. ZM9470/3 medulloblastoma, NOS
  12. DD352A pituitary adenoma
  13. Other rare brain tumours including skull base sarcomas

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      Exclusion Criteria:

      Performance status 3-4 Progression after radiation therapy

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Primary outcomes:
measure: Memory impairment (as assessed by the HVLT-r)
timeFrame: 1-10 years after treatment
measure: Neurocognitive function
timeFrame: 1-10 years after treatment
Secondary outcomes:
measure: Global Health - Quality of life
timeFrame: 1-10 years after treatment
measure: Fatigue
timeFrame: 1-10 years after treatment
measure: Sleep quality
timeFrame: 1-10 years after treatment
measure: Depression/Anxiety
timeFrame: 1-10 years after treatment
measure: Patients assessment of own cognitive function
timeFrame: 1-10 years after treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Midt
Study officials:
affiliation: Aarhus University Hospital
name: Morten Høyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haldbo-Classen L, Amidi A, Lukacova S, Wu LM, Oettingen GV, Lassen-Ramshad Y, Zachariae R, Kallehauge JF, Hoyer M. Cognitive impairment following radiation to hippocampus and other brain structures in adults with primary brain tumours. Radiother Oncol. 2020 Jul;148:1-7. doi: 10.1016/j.radonc.2020.03.023. Epub 2020 Mar 28.