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NCT Number: NCT04118426

Cognitive Function After Radiation Therapy for Brain Tumours

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

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Key information

Conditions

Primary Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radiation Injuries Radiation Toxicity Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted
  • ZM9450/3 oligodendroglioma, NOS
  • ZM9451/3 anaplastic oligodendroglioma, NOS
  • ZM9530/0 meningioma
  • ZM9470/3 medulloblastoma, NOS
  • DD352A pituitary adenoma
  • Other rare brain tumours including skull base sarcomas

-

Exclusion criteria

Performance status 3-4 Progression after radiation therapy

-

Treatment and study plan

Cognitive testing

Radiation

Patients will have their cognitive function tested by the use of standardized cognitive test and fill in questionnaires.

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)

Questionnaire include; Quality of life; EORTC QlQ-C30 (QlQ-C30), FACIT-Fatigue Scale (Version 4) (FACIT), Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), Patient's Assessment of Own Functioning Inventory (PAOFI).

Primary outcomes

  1. 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.

  2. 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

  1. Global Health - Quality of life

    Time frame: 1-10 years after treatment

    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

  2. Fatigue

    Time frame: 1-10 years after treatment

    Assessed by questionnaire: FACIT-Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy

  3. Sleep quality

    Time frame: 1-10 years after treatment

    Assessed by questionnaire:Pittsburg Sleep Quality INDEX, PSQI in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy

  4. Depression/Anxiety

    Time frame: 1-10 years after treatment

    Assessed by questionnaire: Hospital anxiety and depression Scale (HADS) in order to explore level of depression and anxiety in patients treated with radiation therapy for their brain tumour

  5. Patients assessment of own cognitive function

    Time frame: 1-10 years after treatment

    Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: WP-12-pre

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 8, 2019
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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