Primary Brain TumorWP-12-preNCT04118426
Cognitive Function After Radiation Therapy for Brain Tumours
An observational study of Primary Brain Tumor and Radiation Toxicity, run by University of Aarhus at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Brain Tumor, Radiation Toxicity
- What is being tested?
- Cognitive testing
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Feb 2017to 12 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with a primary brain tumour grade I-III
Who may be able to join
- 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
Show all 18Show fewer
- 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
- -
Who cannot join
- Performance status 3-4 Progression after radiation therapy
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Cognitive testing
- Keywords
- Cognitive function
- Medical subject headings
- Brain Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive testingRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy group | Patients receiving radiotherapy after surgery for brain tumor Receives: Radiation: Cognitive testing | |
| No radiotherapy group | Patients NOT receiving radiotherapy after surgery for brain tumor Receives: Radiation: Cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-10 years after treatment
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".
Measured: 1-10 years after treatment
Secondary outcomes (5)
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
Measured: 1-10 years after treatment
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
Measured: 1-10 years after treatment
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
Measured: 1-10 years after treatment
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
Measured: 1-10 years after treatment
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
Measured: 1-10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start7 Feb 2017
- Primary completion2 Feb 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Høyer, University of Aarhus
- Investigators
- Morten Høyer, M.D., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118426
- Sponsor's protocol ID
- WP-12's precursor
- Acronym
- WP-12-pre
- Status last verified
- Oct 2019
- First submitted
- 1 Jun 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32298906
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function After Radiation Therapy for Brain Tumours
- ClinicalTrials.gov ID
- NCT04118426
- Acronym / sponsor ID
- WP-12-pre / WP-12's precursor
- Conditions
- Primary Brain Tumor, Radiation Toxicity
- Keywords
- Cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy group | – | Radiation: Cognitive testingPatients receiving radiotherapy after surgery for brain tumor |
| No radiotherapy group | – | Radiation: Cognitive testingPatients NOT receiving radiotherapy after surgery for brain tumor |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a primary brain tumour grade I-III
Key inclusion criteria (18 listed)
- 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
- -
Key exclusion criteria (2 listed)
- Performance status 3-4 Progression after radiation therapy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive testingPatients 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). | Radiation | No radiotherapy group, Radiotherapy group |
Primary outcome
Memory impairment (as assessed by the HVLT-r)
Time frame: 1-10 years after treatment
To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.
Neurocognitive function
Time frame: 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".
5 secondary outcomes
Global Health - Quality of life
Time frame: 1-10 years after treatment
Fatigue
Time frame: 1-10 years after treatment
Sleep quality
Time frame: 1-10 years after treatment
Depression/Anxiety
Time frame: 1-10 years after treatment
Patients assessment of own cognitive function
Time frame: 1-10 years after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Derived from this study: PubMed 32298906Haldbo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Høyer, M.D. principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Brain Tumor and Radiation Toxicity, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory impairment (as assessed by the HVLT-r) (time frame: 1-10 years after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.