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Cognitive Function After Radiation Therapy for Brain Tumours

Study Purpose

This study will assess cognitive function in adult patients with a primary brain tumour treated with surgical resection with or without radiation therapy (RT). 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:

  • - The participant must be 18 years or older and Danish speaking.
  • - Performance status 0-2.
  • - Capable of cooperating on testing.
  • - Diagnosed with one of the following diagnoses according to WHO 2016 classification 16 and been treated between 2006 and 2016.
1. ZM93803 glioma (exclusive glioblastoma) 2. ZM9401/3 anaplastic astrocytoma, IDH mutant. 3. ZM9400/3 diffuse astrocytoma, IDH-mutant. 4. ZM9411/3 gemistocytisk astrocytoma, IDH mutant. 5. ZM9400/3 diffuse astrocytoma, NOS. 6. ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted. 7. ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted. 8. ZM9450/3 oligodendroglioma, NOS. 9. ZM9451/3 anaplastic oligodendroglioma, NOS. 10. ZM9530/0 meningioma. 11. ZM9470/3 medulloblastoma, NOS. 12. DD352A pituitary adenoma. 13. Other rare brain tumours including skull base sarcomas.
  • -

    Exclusion Criteria:

    Performance status 3-4 Progression after radiation therapy.
-

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.

 NCT04118426
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.

 Morten Høyer, 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 Completed
Countries Denmark
Conditions

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

 Primary Brain Tumor, Radiation Toxicity
Additional Details

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 the investigators need to spare, to prevent cognitive dysfunction. The study is a cross sectional study assessing cognitive function in patients with brain tumours previously treated with RT compared to a similar non irradiated group. 104 patients with specified brain tumours from Aarhus University Hospital treated in the period 2006-2016 will be included. 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.

Arms & Interventions

Arms

: Radiotherapy group

Patients receiving radiotherapy after surgery for brain tumor

: No radiotherapy group

Patients NOT receiving radiotherapy after surgery for brain tumor

Interventions

Radiation: - Cognitive testing

Patients will have their cognitive function tested by the use of standardized cognitive test and fill in questionnaires. Cognitive function will be assessed by standardized cognitive tests: Hopkins verbal learning test (HVLT), Trail Making Test part A and B (TMT A and TMT B), Pased Auditory Test (PASAT), Wechsler Adult Intelligence Scale coding and digit span (WAIS-IV), Controlled Oral Word Association Test (Cowat) and STROOP colour and word test (STROOP) Questionnaire include; Quality of life; EORTC QlQ-C30 (QlQ-C30), FACIT-Fatigue Scale (Version 4) (FACIT), Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), Patient's Assessment of Own Functioning Inventory (PAOFI).

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

Aarhus University Hospital, Aarhus, Region Midt, Denmark

Status

Address

Aarhus University Hospital

Aarhus, Region Midt, 8000

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