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Cognitive Function After Radiation Therapy for Brain Tumours (WP-12-pre)

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Radiation Toxicity
Primary Brain Tumor

Treatments

Radiation: Cognitive testing

Study type

Observational

Funder types

Other

Identifiers

NCT04118426
WP-12's precursor

Details and patient eligibility

About

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

Full 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.

Enrollment

104 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

      Exclusion Criteria:

      Performance status 3-4 Progression after radiation therapy

Trial design

104 participants in 2 patient groups

Radiotherapy group
Description:
Patients receiving radiotherapy after surgery for brain tumor
Treatment:
Radiation: Cognitive testing
No radiotherapy group
Description:
Patients NOT receiving radiotherapy after surgery for brain tumor
Treatment:
Radiation: Cognitive testing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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