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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2021
Source University of Aarhus
Contact Morten Høyer, MD
Phone +45 2328 2823
Email morthoey@rm.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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)

Study Design


Intervention

Other:
Cognitive tests and Patient Reported Outcomes
Each patient will undergo cognitive tests and questionnaires

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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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