Cognitive Function After Radiation Therapy for Primary Brain Tumours

Cognitive Impairment Clinical Trial

Official title:

Cognitive Function After Radiation Therapy for Primary Brain Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306432
• Other study ID #: DNOG-2
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Brain Neoplasms
• Cognitive Impairment
• Primary Brain Tumour
• Radiation Toxicity

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