Cognitive Function After Radiation Therapy for Brain Tumours

Radiation Toxicity Clinical Trial

— WP-12-pre  

Official title:

Cognitive Function After Radiation Therapy for Brain Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118426
• Other study ID #: WP-12's precursor
• Status: Completed
• Start date: February 7, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: October 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 12, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Brain Tumor
• Radiation Toxicity

Intervention

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).

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Region Midt

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory impairment (as assessed by the HVLT-r)	To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.	1-10 years after treatment
Primary	Neurocognitive function	Examine correlations cognitive decline and subvolumes of the brain. 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). Measures on cognitive test is time in seconds or number of "corrects".	1-10 years after treatment
Secondary	Global Health - Quality of life	Assessed by questionnaire; EORTC QlQ-C30 in order to examine the level of quality of life in brain tumour patients who has received radiation therapy	1-10 years after treatment
Secondary	Fatigue	Assessed by questionnaire: FACIT-Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy	1-10 years after treatment
Secondary	Sleep quality	Assessed by questionnaire:Pittsburg Sleep Quality INDEX, PSQI in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy	1-10 years after treatment
Secondary	Depression/Anxiety	Assessed by questionnaire: Hospital anxiety and depression Scale (HADS) in order to explore level of depression and anxiety in patients treated with radiation therapy for their brain tumour	1-10 years after treatment
Secondary	Patients assessment of own cognitive function	Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function	1-10 years after treatment