Cognitive Function After Radiation Therapy for Brain Tumours

NCT ID: NCT04118426

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2018-04-12

Brief Summary

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

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 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.

Conditions

Primary Brain Tumor; Radiation Toxicity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Radiotherapy group

Patients receiving radiotherapy after surgery for brain tumor

Cognitive testing

Intervention Type: RADIATION

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).

No radiotherapy group

Patients NOT receiving radiotherapy after surgery for brain tumor

Cognitive testing

Intervention Type: RADIATION

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).

Interventions

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).

Intervention Type: RADIATION

Eligibility 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

-

• 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

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, Region Midt, Denmark

Countries

Denmark

References

Haldbo-Classen L, Amidi A, Lukacova S, Wu LM, Oettingen GV, Lassen-Ramshad Y, Zachariae R, Kallehauge JF, Hoyer M. Cognitive impairment following radiation to hippocampus and other brain structures in adults with primary brain tumours. Radiother Oncol. 2020 Jul;148:1-7. doi: 10.1016/j.radonc.2020.03.023. Epub 2020 Mar 28.

Reference Type: DERIVED

PMID: 32298906 (View on PubMed)

Other Identifiers

WP-12's precursor

Identifier Type: -

Identifier Source: org_study_id