An observational study in Primary Brain Tumour, Radiation Toxicity and Cognitive Impairment, sponsored by University of Aarhus. Recruiting at 5 sites in Denmark. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-02.
Sponsored by University of Aarhus · Observational
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.
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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The patients will be diagnosed with a primary brain tumour and referred to radiation therapy.
Exclusion Criteria:
Each patient will undergo cognitive tests and questionnaires
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
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
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
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
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
Verbal fluency
Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter_S. Outcome is number of words produced in 1 minute (0-100)
Time frame: 10 years
Executive function I
Examined by Trail making Test part B (TMT_B). Outcome for TMT_B is time in seconds (0-300).
Time frame: 10 years
Executive function II
Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120)
Time frame: 10 years
Global Health - Quality of life
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)
Time frame: 10 years
Side effects to radiation therapy
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)
Time frame: 10 years
Quality of Sleep
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)
Time frame: 10 years
Fatigue
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)
Time frame: 10 years
Depression/Anxiety
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)
Time frame: 10 years
Patient's Assessment of Own Functioning
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)
Time frame: 10 years
Plan to share: No
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