Cerebral Morbidity After Radiation Therapy for Brain Tumors

NCT ID: NCT04292353

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2024-09-30

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.

Detailed Description

RT to brain tumours causes cognitive dysfunction. The extent of RT induced changes in cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive dysfunction. There is modest knowledge on which parts of the brain we need to spare, to prevent cognitive dysfunction.

The study is a prospective nationwide study including approximately 60 brain tumour patients from the four neuro oncology centres in Denmark. The patients will do patient reported outcome (PRO) and undergo neuropsychological assessment with standardized tests: They will do this prior to RT treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on quality of life, fatigue, sleep, depression, anxiety, and socio demografica. 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; Paced Auditory Serial Addition Test (PASAT). 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.

Conditions

Brain Tumor; Cognitive Impairment; Radiation Toxicity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cognitive tests and Patient Reported Outcome

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years or older and Danish speaking.
• Performance status WHO 0-2
• Capable of cooperating on testing
• Tumor histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas

Exclusion Criteria

• Glioblastoma
• Performance status 3-4

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Morten Høyer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Høyer, M.D

Role: PRINCIPAL_INVESTIGATOR

Danish Center for Particel Therapy, Aarhus University Hospital, Denmark

Locations

Rigshospital

Copenhagen, Region H, Denmark

Department of Oncology

Aarhus, Region Midt, Denmark

Aalborg University Hospital

Aalborg, Region Nord, Denmark

Odense University Hospital

Odense, Region Syd, Denmark

Countries

Denmark

Other Identifiers

WP-12

Identifier Type: -

Identifier Source: org_study_id