Health TrialsbyHealthPanel

Cognitive Function After Radiation Therapy for Primary Brain Tumours

ConditionsPrimary Brain TumourRadiation ToxicityCognitive Impairment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older and Danish speaking.

Performance status WHO 0-2

Capable of cooperating on testing

Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas

Disqualifiers

Glioblastoma

Performance status 3-4 (Karnofsky Performances of 60 or less)

Trial population

The patients will be diagnosed with a primary brain tumour and referred to radiation therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cognitive tests and Patient Reported Outcomes

    Other intervention

    Each patient will undergo cognitive tests and questionnaires

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Impairment of verbal learning and memory as assessed by the HVLT-r test

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

Time frame
10 Years

Secondary outcomes

1

Processing speed I

Examined by the Trail making Test part A (TMT\_A). Outcome for TMT\_A is time in seconds (0-120 seconds).

Time frame
10 years
2

Processing speed II

Examined by the Coding from Wechsler Adult Intelligence Scale (WAIS-IV). Outcome for Coding is number of correct (within 2 minutes) (0-100)

Time frame
10 years
3

Attention and working memory

Examined by Wechsler Adult Intelligence Scale (WAIS\_IV\_digit\_span). Outcome on WAIS digit span is number of correct (0-36)

Time frame
10 years
4

Verbal learning and memory

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

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Source ClinicalTrials.gov
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