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Clinical Trials/NCT04118426
NCT04118426
Completed
Not Applicable

Cognitive Function After Radiation Therapy for Brain Tumours

University of Aarhus1 site in 1 country104 target enrollmentFebruary 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Brain Tumor
Sponsor
University of Aarhus
Enrollment
104
Locations
1
Primary Endpoint
Memory impairment (as assessed by the HVLT-r)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 7, 2017
End Date
April 12, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Morten Høyer

Professor

University of Aarhus

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
  • ZM93803 glioma (exclusive glioblastoma)
  • ZM9401/3 anaplastic astrocytoma, IDH mutant
  • ZM9400/3 diffuse astrocytoma, IDH-mutant
  • ZM9411/3 gemistocytisk astrocytoma, IDH mutant
  • ZM9400/3 diffuse astrocytoma, NOS
  • ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted

Exclusion Criteria

  • Performance status 3-4 Progression after radiation therapy

Outcomes

Primary Outcomes

Memory impairment (as assessed by the HVLT-r)

Time Frame: 1-10 years after treatment

To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.

Neurocognitive function

Time Frame: 1-10 years after treatment

Examine correlations cognitive decline and subvolumes of the brain. Cognitive function will be assessed by standardized cognitive tests: Hopkins verbal learning test (HVLT), Trail Making Test part A and B (TMT A and TMT B), Pased Auditory Test (PASAT), Wechsler Adult Intelligence Scale coding and digit span (WAIS-IV), Controlled Oral Word Association Test (Cowat) and STROOP colour and word test (STROOP). Measures on cognitive test is time in seconds or number of "corrects".

Secondary Outcomes

  • Global Health - Quality of life(1-10 years after treatment)
  • Patients assessment of own cognitive function(1-10 years after treatment)
  • Sleep quality(1-10 years after treatment)
  • Depression/Anxiety(1-10 years after treatment)
  • Fatigue(1-10 years after treatment)

Study Sites (1)

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