WP-12-pre: Cognitive Function After Radiation Therapy for Brain Tumours

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT04118426

Collaborator

(none)

104

Enrollment

Location

14.1

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Brain Tumor Radiation Toxicity	Radiation: Cognitive testing

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.

Study Design

Study Type:

Observational

Actual Enrollment :

104 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Cognitive Function After Radiation Therapy for Brain Tumours

Actual Study Start Date :

Feb 7, 2017

Actual Primary Completion Date :

Feb 2, 2018

Actual Study Completion Date :

Apr 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Radiotherapy group Patients receiving radiotherapy after surgery for brain tumor	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).
No radiotherapy group Patients NOT receiving radiotherapy after surgery for brain tumor	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).

Arm

Intervention/Treatment

Radiotherapy group

Patients receiving radiotherapy after surgery for brain tumor

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).

No radiotherapy group

Patients NOT receiving radiotherapy after surgery for brain tumor

Radiation: Cognitive testing

Outcome Measures

Primary Outcome Measures

Memory impairment (as assessed by the HVLT-r) [1-10 years after treatment]
To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.
Neurocognitive function [1-10 years after treatment]
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".

Secondary Outcome Measures

Global Health - Quality of life [1-10 years after treatment]
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
Fatigue [1-10 years after treatment]
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
Sleep quality [1-10 years after treatment]
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
Depression/Anxiety [1-10 years after treatment]
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
Patients assessment of own cognitive function [1-10 years after treatment]
Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

ZM93803 glioma (exclusive glioblastoma)
ZM9401/3 anaplastic astrocytoma, IDH mutant
ZM9400/3 diffuse astrocytoma, IDH-mutant
ZM9411/3 gemistocytisk astrocytoma, IDH mutant
ZM9400/3 diffuse astrocytoma, NOS
ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted
ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted
ZM9450/3 oligodendroglioma, NOS
ZM9451/3 anaplastic oligodendroglioma, NOS
ZM9530/0 meningioma
ZM9470/3 medulloblastoma, NOS
DD352A pituitary adenoma
Other rare brain tumours including skull base sarcomas

Exclusion Criteria:

Performance status 3-4 Progression after radiation therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus	Region Midt	Denmark	8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator: Morten Høyer, M.D., Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morten Høyer, Professor, University of Aarhus

ClinicalTrials.gov Identifier:

NCT04118426

Other Study ID Numbers:

WP-12's precursor

First Posted:

Oct 8, 2019

Last Update Posted:

Oct 10, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Morten Høyer, Professor, University of Aarhus

Cognitive function

Additional relevant MeSH terms:

Brain Neoplasms

Study Results

No Results Posted as of Oct 10, 2019