Cognitive Function After Radiation Therapy for Primary Brain Tumours

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04306432
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Aarhus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lene Haldbo-Classen, M.D
Principal Investigator Affiliation Aarhus University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Brain Tumour, Radiation Toxicity, Cognitive Impairment
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Department of Oncology, Rigshospitalet, Copenhagen, Region Hovedstaden, Denmark

Status

Recruiting

Address

Department of Oncology, Rigshospitalet

Copenhagen, Region Hovedstaden, 2100

Site Contact

Aida Muhic

[email protected]

+45 35456942

Danish Center for Particel Therapy, Aarhus, Region Midt, Denmark

Status

Recruiting

Address

Danish Center for Particel Therapy

Aarhus, Region Midt, 8200

Site Contact

Morten Høyer

[email protected]

+452328 2823

Aarhus, Region Midt, Denmark

Status

Recruiting

Address

Department of Oncology, Aarhus University Hospital

Aarhus, Region Midt, 8200

Site Contact

Slavka Lucakova

[email protected]

+45 3027 2470

Aalborg, Region Nord, Denmark

Status

Recruiting

Address

Department of Oncology, Aalborg University Hospital

Aalborg, Region Nord, 9000

Site Contact

Charlotte Haslund

[email protected]

+45 97661414

Odense, Region Syd, Denmark

Status

Recruiting

Address

Department of Oncology, Odense University Hospital

Odense, Region Syd, 5000

Site Contact

Rikke Dahlrot

[email protected]

+45 26242142

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