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NCT Number: NCT04306432

Cognitive Function After Radiation Therapy for Primary Brain Tumours

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.

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Key information

Conditions

Primary Brain Tumour Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurocognitive Disorders Radiation Injuries Radiation Toxicity Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Rigshospitalet, Copenhagen, Capital Region, Denmark

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About this study

RT is fundamental in the treatment of primary brain tumours. RT contributes to improved local control and prolonged progression-free survival in patients with a broad range of tumour types. Irradiation to the normal brain may lead to cognitive impairments. Clarifying the nature and severity of impairment in adult RT-treated brain tumour patients, including region-specific effects, are important for optimal utilization of novel conformal RT technologies such as proton therapy.

The study is a prospective nationwide study including approximately 300 brain tumour patients from the Danish Center of Particle Therapy and the four Neuro Oncology Centers in Denmark.

The patients will be assessed with a comprehensive battery of standardized cognitive tests and complete a questionnaire (PRO's). They will do this prior to RT treatment and 1, 3, 5 and 10 years afterwards. The PRO's includes measures on quality of life, fatigue, sleep, depression, anxiety, and socio demographics. 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. The correlation between cognitive scores and RT dose-volume parameters to specific areas in the brain will be tested.

This study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Cognitive tests and Patient Reported Outcomes

Other

Each patient will undergo cognitive tests and questionnaires

Primary outcomes

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

    Time frame: 10 Years

    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)

Secondary outcomes

  1. Processing speed I

    Time frame: 10 years

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

  2. Processing speed II

    Time frame: 10 years

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

  3. Attention and working memory

    Time frame: 10 years

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

  4. Verbal learning and memory

    Time frame: 10 years

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

  5. Verbal fluency

    Time frame: 10 years

    Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter_S. Outcome is number of words produced in 1 minute (0-100)

  6. Executive function I

    Time frame: 10 years

    Examined by Trail making Test part B (TMT_B). Outcome for TMT_B is time in seconds (0-300).

  7. Executive function II

    Time frame: 10 years

    Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120)

  8. Global Health - Quality of life

    Time frame: 10 years

    Assessed by questionnaire; European organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in order to examine the level of quality of life in brain tumour patients who has received radiation therapy. The total score is a number (0-100)

  9. Side effects to radiation therapy

    Time frame: 10 years

    Assessed by EORTC Brain Neoplasm Questionnaire, BN20 (an addition to QLQ-C30 mentioned above) in order to measure side effects to radiation therapy for a brain tumour. the score is a number (0-100)

  10. Quality of Sleep

    Time frame: 10 years

    Assessed by questionnaire: Pittsburgh Sleep Quality INDEX, (PSQI) in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy. Outcome is a number (0-33)

  11. Fatigue

    Time frame: 10 years

    Assessed by questionnaire: Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy. Outcome is a number (0-52)

  12. Depression/Anxiety

    Time frame: 10 years

    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. Outcome is a number (0-56)

  13. Patient's Assessment of Own Functioning

    Time frame: 10 years

    Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function. Outcome is a number (35-210)

Study contacts

Contact information is provided by the study sponsor or research team.

Lene Haldbo-Classen, MD

CONTACT

[email protected]

+4523342761

Morten Høyer, MD

CONTACT

[email protected]

+45 2328 2823

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2019
Primary completion
2034
Study completion
2034
First posted
Mar 12, 2020
Registry last updated
Dec 2, 2021

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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