NCT04118426

Cognitive Function After Radiation Therapy for Brain Tumours

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-02-07
• Primary completion: 2018-02-02
• Completion: 2018-04-12
• First posted: 2019-10-08
• Last updated: 2019-10-10

Locations

1 site across 1 country: Denmark