Brain TumorWP-12NCT04292353
Cerebral Morbidity After Radiation Therapy for Brain Tumors
An observational study of Brain Tumor and Cognitive Impairment, run by University of Aarhus at 4 sites in Denmark.
Trial summary
This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. 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
- Brain Tumor, Cognitive Impairment, Radiation Toxicity
- What is being tested?
- Cognitive tests and Patient Reported Outcome
- How many people
- 67 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Jul 2016to 30 Sep 2024
- 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: The patients will be diagnosed with a primary brain tumour and referred to radiation therapy. They will be recruited from the four neuro oncology centers in Denmark
Who may be able to join
- 18 years or older and Danish speaking.
- Performance status WHO 0-2
- Capable of cooperating on testing
- Tumor histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas
Who cannot join
- Glioblastoma
- Performance status 3-4
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, Region Nord, 9000
Department of Oncology
Aarhus, Region Midt, 8000
Rigshospital
Copenhagen, Region H, 2100
Odense University Hospital
Odense, Region Syd, 5000
About this study
This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. 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 we need to spare, to prevent cognitive dysfunction.
The study is a prospective nationwide study including approximately 60 brain tumour patients from the four neuro oncology centres in Denmark. 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.
This study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.
- Conditions
- Brain Tumor, Cognitive Impairment, Radiation Toxicity
- Being tested
- Cognitive tests and Patient Reported Outcome
- Keywords
- Brain tumor, Cognitive function, Radiation Therapy, Hippocampus
- Medical subject headings
- Brain Neoplasms, Cognitive Dysfunction, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tests and Patient Reported OutcomeOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment of memory as assessed by the HVLT-r test
Examined by the Hopkins Verbal Learning Test. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)
Measured: 5 Years
Secondary outcomes (10)
Processing speed
Examined by the Trail making Test part A (TMT_A) and the Coding from WAIS-IV. Outcome for TMT_A is time in seconds (0-120 seconds). Outcome for Coding is number of correct (within 2 minutes) (0-100)
Measured: 5 Years
Attention and working memory
Examined by WAIS_IV_digit_span and PASAT (Pased Auditory Seriel Addition Test). Outcome on WAIS digit span is number of correct (0-36) and outcome for PASAT is number of incorrects (0-60)
Measured: 5 Years
Verbal learning and memory
Examine by the Hopkins Verbal Learning Test (HVLT) - total and delayed. Outcome is number of correct words (0-24)
Measured: 5 Years
Verbal fluency
Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter_S. Outcome is number of words produced in 1 minute (0-100)
Measured: 5 Years
Executive function
Examined by Trail making Test part B (TMT-B) and the STROOP colour and word test (STROOP). Outcome for TMT_B is time in seconds (0-300). Outcome for STROOP is number of corrects (0-120)
Measured: 5 Years
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. Quality of life will be assessed by EORTC QIQ-C-30
Measured: 5 Years
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: 5 years
Qulity of Sleep
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: 5 years
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: 5 years
Patient's Assessment of Own Functioning Inventory
Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jul 2016
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 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, Danish Center for Particel Therapy, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292353
- Sponsor's protocol ID
- WP-12
- Acronym
- WP-12
- Status last verified
- May 2021
- First submitted
- 1 Jun 2018
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Morbidity After Radiation Therapy for Brain Tumors
- ClinicalTrials.gov ID
- NCT04292353
- Acronym / sponsor ID
- WP-12 / WP-12
- Conditions
- Brain Tumor, Cognitive Impairment, Radiation Toxicity
- Keywords
- Brain tumor, Cognitive function, Radiation Therapy, Hippocampus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 3 Mar 2020 (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 patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. 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 we need to spare, to prevent cognitive dysfunction.
The study is a prospective nationwide study including approximately 60 brain tumour patients from the four neuro oncology centres in Denmark. 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.
This study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be diagnosed with a primary brain tumour and referred to radiation therapy. They will be recruited from the four neuro oncology centers in Denmark
Key inclusion criteria (4 listed)
- 18 years or older and Danish speaking.
- Performance status WHO 0-2
- Capable of cooperating on testing
- Tumor histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas
Key exclusion criteria (2 listed)
- Glioblastoma
- Performance status 3-4
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 tests and Patient Reported Outcome | Other | – |
Primary outcome
Impairment of memory as assessed by the HVLT-r test
Time frame: 5 Years
Examined by the Hopkins Verbal Learning Test. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)
10 secondary outcomes
Processing speed
Time frame: 5 Years
Attention and working memory
Time frame: 5 Years
Verbal learning and memory
Time frame: 5 Years
Verbal fluency
Time frame: 5 Years
Executive function
Time frame: 5 Years
Global Health - Quality of life
Time frame: 5 Years
Fatigue
Time frame: 5 years
Qulity of Sleep
Time frame: 5 years
Depression/Anxiety
Time frame: 5 years
Patient's Assessment of Own Functioning Inventory
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- 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
Danish Center for Particel Therapy, Aarhus University Hospital, Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Cognitive Impairment, run by University of Aarhus at 4 sites 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 4 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: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
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?
Impairment of memory as assessed by the HVLT-r test (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2021.