Cognitive Impairment Clinical Trial
Official title:
Cognitive Function After Radiation Therapy for Primary Brain Tumours
NCT number | NCT04306432 |
Other study ID # | DNOG-2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 3, 2019 |
Est. completion date | March 31, 2034 |
Verified date | May 2021 |
Source | University of Aarhus |
Contact | Morten Høyer, MD |
Phone | +45 2328 2823 |
morthoey[@]rm.dk | |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | March 31, 2034 |
Est. primary completion date | March 31, 2034 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Aalborg University Hospital | Aalborg | Region Nord |
Denmark | Danish Center for Particel Therapy | Aarhus | Region Midt |
Denmark | Department of Oncology, Aarhus University Hospital | Aarhus | Region Midt |
Denmark | Department of Oncology, Rigshospitalet | Copenhagen | Region Hovedstaden |
Denmark | Department of Oncology, Odense University Hospital | Odense | Region Syd |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 10 Years | |
Secondary | Processing speed I | Examined by the Trail making Test part A (TMT_A). Outcome for TMT_A is time in seconds (0-120 seconds). | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | Executive function I | Examined by Trail making Test part B (TMT_B). Outcome for TMT_B is time in seconds (0-300). | 10 years | |
Secondary | Executive function II | Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years | |
Secondary | 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) | 10 years |
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