MedDataX Logo

Cognitive Function After Radiation Therapy for Primary Brain Tumours

NCT ID: NCT04306432

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-03

Study Completion Date

2034-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Brain Tumour Radiation Toxicity Cognitive Impairment

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Brain tumour Radiation therapy Cognitive function Hippocampus Patient reported outcomes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive tests and Patient Reported Outcomes

Each patient will undergo cognitive tests and questionnaires

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lene Haldbo-Classen, M.D

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Oncology, Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Danish Center for Particel Therapy

Aarhus, Region Midt, Denmark

Site Status RECRUITING

Department of Oncology, Aarhus University Hospital

Aarhus, Region Midt, Denmark

Site Status RECRUITING

Department of Oncology, Aalborg University Hospital

Aalborg, Region Nord, Denmark

Site Status RECRUITING

Department of Oncology, Odense University Hospital

Odense, Region Syd, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Morten Høyer, MD

Role: CONTACT

Phone: +45 2328 2823

Email: [email protected]

Lene Haldbo-Classen, MD

Role: CONTACT

Phone: +4523342761

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aida Muhic

Role: primary

Morten Høyer

Role: primary

Lene Haldbo-Classen

Role: backup

Slavka Lucakova

Role: primary

Charlotte Haslund

Role: primary

Rikke Dahlrot

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DNOG-2

Identifier Type: -

Identifier Source: org_study_id