Primary Brain TumourNCT04306432
Cognitive Function After Radiation Therapy for Primary Brain Tumours
An observational study of Primary Brain Tumour and Radiation Toxicity, run by University of Aarhus at 5 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
- Primary Brain Tumour, Radiation Toxicity, Cognitive Impairment
- What is being tested?
- Cognitive tests and Patient Reported Outcomes
- How many people
- 300 participants
- Where
- 5 sitesDenmark
- Study dates
- 3 Jan 2019to 31 Mar 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
Who may be able to join
- 18 years or older and Danish speaking.
- Performance status WHO 0-2
- Capable of cooperating on testing
- Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas
Who cannot join
- Glioblastoma
- Performance status 3-4 (Karnofsky Performances of 60 or less)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Department of Oncology, Aalborg University Hospital
Aalborg, Region Nord, 9000
Charlotte Haslund, +45 97661414, cah@rn.dk
- Recruiting
Danish Center for Particel Therapy
Aarhus, Region Midt, 8200
Morten Høyer, +452328 2823, morthoey@rm.dk
Lene Haldbo-Classen, +45 2334 2761 ext. +4523342761, lenhaldb@rm.dk
- Recruiting
Department of Oncology, Aarhus University Hospital
Aarhus, Region Midt, 8200
Slavka Lucakova, +45 3027 2470, slvkluka@rm.dk
Lene Haldbo-Classen
- Recruiting
Department of Oncology, Rigshospitalet
Copenhagen, Capital Region, 2100
Aida Muhic, +45 35456942, aida.muhic@regionh.dk
- Recruiting
Department of Oncology, Odense University Hospital
Odense, Region Syd, 5000
Rikke Dahlrot, +45 26242142, rikke.dahlrot@rsyd.dk
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 is fundamental in the treatment of primary brain tumours. RT contributes to improved local control and prolonged progression-free survival in patients with a broad range of tumour types. Irradiation to the normal brain may lead to cognitive impairments. Clarifying the nature and severity of impairment in adult RT-treated brain tumour patients, including region-specific effects, are important for optimal utilization of novel conformal RT technologies such as proton therapy.
The study is a prospective nationwide study including approximately 300 brain tumour patients from the Danish Center of Particle Therapy and the four Neuro Oncology Centers in Denmark.
The patients will be assessed with a comprehensive battery of standardized cognitive tests and complete a questionnaire (PRO's). They will do this prior to RT treatment and 1, 3, 5 and 10 years afterwards. The PRO's includes measures on quality of life, fatigue, sleep, depression, anxiety, and socio demographics. 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. 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.
- Being tested
- Cognitive tests and Patient Reported Outcomes
- Keywords
- Brain tumour, Radiation therapy, Cognitive function, Hippocampus, Patient reported outcomes
- Medical subject headings
- Radiation Injuries, Cognitive Dysfunction, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tests and Patient Reported OutcomesOther
Each patient will undergo cognitive tests and questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment of verbal learning and memory as assessed by the HVLT-r test
Examined by the Hopkins Verbal Learning Test revised. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)
Measured: 10 Years
Secondary outcomes (13)
Processing speed I
Examined by the Trail making Test part A (TMT_A). Outcome for TMT_A is time in seconds (0-120 seconds).
Measured: 10 years
Processing speed II
Examined by the Coding from Wechsler Adult Intelligence Scale (WAIS-IV). Outcome for Coding is number of correct (within 2 minutes) (0-100)
Measured: 10 years
Attention and working memory
Examined by Wechsler Adult Intelligence Scale (WAIS_IV_digit_span). Outcome on WAIS digit span is number of correct (0-36)
Measured: 10 years
Verbal learning and memory
Examine by the Hopkins Verbal Learning Test revised (HVLT-r) - total and delayed. Outcome is number of correct words (0-24)
Measured: 10 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: 10 years
Executive function I
Examined by Trail making Test part B (TMT_B). Outcome for TMT_B is time in seconds (0-300).
Measured: 10 years
Executive function II
Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120)
Measured: 10 years
Global Health - Quality of life
Assessed by questionnaire; European organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in order to examine the level of quality of life in brain tumour patients who has received radiation therapy. The total score is a number (0-100)
Measured: 10 years
Side effects to radiation therapy
Assessed by EORTC Brain Neoplasm Questionnaire, BN20 (an addition to QLQ-C30 mentioned above) in order to measure side effects to radiation therapy for a brain tumour. the score is a number (0-100)
Measured: 10 years
Quality of Sleep
Assessed by questionnaire: Pittsburgh Sleep Quality INDEX, (PSQI) in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy. Outcome is a number (0-33)
Measured: 10 years
Fatigue
Assessed by questionnaire: Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy. Outcome is a number (0-52)
Measured: 10 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. Outcome is a number (0-56)
Measured: 10 years
Patient's Assessment of Own Functioning
Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function. Outcome is a number (35-210)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start3 Jan 2019
- Primary completion31 Mar 2034 (estimated)
- Study completion31 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumourStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Haldbo-Classen, M.D, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306432
- Sponsor's protocol ID
- DNOG-2
- Status last verified
- May 2021
- First submitted
- 10 Mar 2020
- Last updated
- 2 Dec 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 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function After Radiation Therapy for Primary Brain Tumours
- ClinicalTrials.gov ID
- NCT04306432
- Acronym / sponsor ID
- DNOG-2
- Keywords
- Brain tumour, Radiation therapy, Cognitive function, Hippocampus, Patient reported outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 31 Mar 2034 (estimated)
- Study completion
- 31 Mar 2034 (estimated)
- First posted
- 12 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 is fundamental in the treatment of primary brain tumours. RT contributes to improved local control and prolonged progression-free survival in patients with a broad range of tumour types. Irradiation to the normal brain may lead to cognitive impairments. Clarifying the nature and severity of impairment in adult RT-treated brain tumour patients, including region-specific effects, are important for optimal utilization of novel conformal RT technologies such as proton therapy.
The study is a prospective nationwide study including approximately 300 brain tumour patients from the Danish Center of Particle Therapy and the four Neuro Oncology Centers in Denmark.
The patients will be assessed with a comprehensive battery of standardized cognitive tests and complete a questionnaire (PRO's). They will do this prior to RT treatment and 1, 3, 5 and 10 years afterwards. The PRO's includes measures on quality of life, fatigue, sleep, depression, anxiety, and socio demographics. 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. 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.
Key inclusion criteria (4 listed)
- 18 years or older and Danish speaking.
- Performance status WHO 0-2
- Capable of cooperating on testing
- Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas
Key exclusion criteria (2 listed)
- Glioblastoma
- Performance status 3-4 (Karnofsky Performances of 60 or less)
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 OutcomesEach patient will undergo cognitive tests and questionnaires | Other | – |
Primary outcome
Impairment of verbal learning and memory as assessed by the HVLT-r test
Time frame: 10 Years
Examined by the Hopkins Verbal Learning Test revised. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)
13 secondary outcomes
Processing speed I
Time frame: 10 years
Processing speed II
Time frame: 10 years
Attention and working memory
Time frame: 10 years
Verbal learning and memory
Time frame: 10 years
Verbal fluency
Time frame: 10 years
Executive function I
Time frame: 10 years
Executive function II
Time frame: 10 years
Global Health - Quality of life
Time frame: 10 years
Side effects to radiation therapy
Time frame: 10 years
Quality of Sleep
Time frame: 10 years
Fatigue
Time frame: 10 years
Depression/Anxiety
Time frame: 10 years
Patient's Assessment of Own Functioning
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
Lene Haldbo-Classen, M.D principal investigator
Aarhus University Hospital
5 sites 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 Tumour and Radiation Toxicity, run by University of Aarhus at 5 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: looking for participants now, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morten Høyer, MD (+45 2328 2823, morthoey@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairment of verbal learning and memory as assessed by the HVLT-r test (time frame: 10 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 2 Dec 2021.