Cognitive Function After Radiation Therapy for Primary Brain Tumours

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT04306432

Collaborator

(none)

300

Enrollment

Locations

182.9

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Brain Tumour Radiation Toxicity Cognitive Impairment	Other: Cognitive tests and Patient Reported Outcomes

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cognitive Function After Radiation Therapy for Primary Brain Tumours

Actual Study Start Date :

Jan 3, 2019

Anticipated Primary Completion Date :

Mar 31, 2034

Anticipated Study Completion Date :

Mar 31, 2034

Outcome Measures

Primary Outcome Measures

Impairment of verbal learning and memory as assessed by the HVLT-r test [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 Outcome Measures

Processing speed I [10 years]
Examined by the Trail making Test part A (TMT_A). Outcome for TMT_A is time in seconds (0-120 seconds).
Processing speed II [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)
Attention and working memory [10 years]
Examined by Wechsler Adult Intelligence Scale (WAIS_IV_digit_span). Outcome on WAIS digit span is number of correct (0-36)
Verbal learning and memory [10 years]
Examine by the Hopkins Verbal Learning Test revised (HVLT-r) - total and delayed. Outcome is number of correct words (0-24)
Verbal fluency [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)
Executive function I [10 years]
Examined by Trail making Test part B (TMT_B). Outcome for TMT_B is time in seconds (0-300).
Executive function II [10 years]
Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120)
Global Health - Quality of life [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)
Side effects to radiation therapy [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)
Quality of Sleep [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)
Fatigue [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)
Depression/Anxiety [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)
Patient's Assessment of Own Functioning [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, Rigshospitalet	Copenhagen	Region Hovedstaden	Denmark	2100
2	Danish Center for Particel Therapy	Aarhus	Region Midt	Denmark	8200
3	Department of Oncology, Aarhus University Hospital	Aarhus	Region Midt	Denmark	8200
4	Department of Oncology, Aalborg University Hospital	Aalborg	Region Nord	Denmark	9000
5	Department of Oncology, Odense University Hospital	Odense	Region Syd	Denmark	5000