Cancer-related Cognitive ImpairmentNCT03452436
Testosterone, Cognition, Ageing, and Cancer
An observational study of Cancer-related Cognitive Impairment, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary aim of the study is - in a prospective controlled design - to examine whether treatment-induced decreases in testosterone acts as a mechanism of cancer-related cognitive impairment (CRCI) in testicular and prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer-related Cognitive Impairment
- How many people
- 133 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Feb 2018to 1 Mar 2020
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men with testicular and prostate cancer seen at Aarhus University Hospital. Age- and education matched healthy controls recruited from the general population of Central Denmark Region.
Who may be able to join
- Confirmed diagnosis of testicular cancer
- Confirmed diagnosis of prostate cancer and prescription of medical castration and radiotherapy
Who cannot join
- Previous cancer disease
- Previous central nervous system disease
- Brain metastases
- Severe psychiatric disease (e.g., schizophrenia, major depressive disorder)
- Insufficient Danish proficiency for neuropsychological testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testosterone, Cognition, Ageing, and Cancer - A Controlled, Prospective Study About the Association Between Testosterone and the Prevalence and Severity of Cancer Related Cognitive Impairment in Testicular and Prostate Cancer Patients.
The primary aim of the study is - in a prospective controlled design - to examine whether treatment-induced decreases in testosterone acts as a mechanism of cancer-related cognitive impairment (CRCI) in testicular and prostate cancer patients.
Secondary aims are 1) to explore whether decreases in testosterone interacts with increasing age to cause more severe CRCI in older patients, 2) to explore underlying neurophysiological (brain morphology) mechanisms of CRCI, and 3) to evaluate selected genetic variants as possible moderators of CRCI.
Read the detailed description
The study will include three groups with a total of 120 participants: A) Forty testicular cancer patients will be included and examined 1) shortly after orchiectomy and prior to any further treatment and 2) at 6 months' follow- up. B) Forty prostate cancer patients will be included and examined at two time-points: 1) prior to initiation of medical castration and radiotherapy and 2) at 6 months' follow- up. C) Forty age- and education-matched healthy controls will be included and assessed at a similar time-interval, i.e., at an initial examination and at a 6 month follow-up. Measures include a battery of neuropsychological/ cognitive tests, questionnaires, blood samples, and Magnetic Resonance Imaging (MRI).
Primary hypothesis
- Treatment-induced decreases in testosterone will be associated with decline in global cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients. Secondary hypotheses
- Treatment-induced decreases in testosterone will be associated with decline in individual cognitive domains (i.e., processing speed, attention, verbal fluency, executive functioning, working memory, verbal learning and memory, visuospatial learning and memory, and visuospatial ability) from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
- Decline in cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients will correspond to changes in grey matter as measured by T1-weighted MRI.
- Decline in cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients will correspond to changes in brain white matter as measured with diffusion-weighted MRI.
- Treatment-induced decreases in testosterone will be more strongly associated with decline in cognitive functioning in prostate cancer patients compared with testicular cancer patients due to more advanced age in the former group.
- Treatment-induced decreases in testosterone will be more strongly associated with decline in cognitive functioning in both testicular and prostate cancer patients carrying the the Apolipoprotein E (APOE) ε4 allele, the Val catechol-O-methyltranferase (COMT) allele, the Val/Val Brain- derived neurotrophic factor (BDNF) genotype, and a short polymorphic CAG repeat length of the Androgen Receptor (AR) gene.
- Treatment-induced decreases in testosterone will be associated with increases in neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition) from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
- Treatment-induced decreases in testosterone will be associated with decreases in health-related quality of life from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
- Treatment-induced decreases in testosterone will be associated with decreases in perceived cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
- Conditions
- Cancer-related Cognitive Impairment
- Keywords
- Cancer-related Cognitive Impairment, Cognitive Dysfunction, Cognition Disorders, Neurocognitive Disorder, Testosterone, Endocrinology, Testicular Cancer, Prostate Cancer
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders, Neurocognitive Disorders, Testicular Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Testicular cancer patients | Forty testicular cancer patients included after orchiectomy but prior to any further treatment. | |
| Prostate cancer patients | Forty prostate cancer patients included prior to medical castration and radiotherapy. | |
| Healthy controls | Forty age- and education-matched healthy controls (20 matched to testicular cancer patients, 20 matched to prostate cancer patients). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive functioning
Changes in global cognitive composite score as measured with neuropsychological tests specified under "Secondary Outcome Measures".
Measured: Baseline and 6 months' follow-up
Secondary outcomes (26)
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Matrix Reasoning.
Measured: Baseline and 6 months' follow-up
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Figure Weights.
Measured: Baseline and 6 months' follow-up
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Visual Puzzles.
Measured: Baseline and 6 months' follow-up
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Block Design.
Measured: Baseline and 6 months' follow-up
Processing speed
Changes in processing speed as measured with Trail Making Test A.
Measured: Baseline and 6 months' follow-up
Processing speed
Changes in processing speed as measured with WAIS-IV Coding.
Measured: Baseline and 6 months' follow-up
Attention
Changes in attention as measured with WAIS-IV Digit Span Forwards.
Measured: Baseline and 6 months' follow-up
Executive functioning
Changes in executive functioning as measured with Trail Making Test B.
Measured: Baseline and 6 months' follow-up
Executive functioning
Changes in executive functioning as measured with Wisconsin Card Sorting Test.
Measured: Baseline and 6 months' follow-up
Working memory
Changes in working memory as measured with WAIS-IV Digit Span Sequencing.
Measured: Baseline and 6 months' follow-up
Working memory
Changes in working memory as measured with WAIS-IV Digit Span Backwards.
Measured: Baseline and 6 months' follow-up
Verbal fluency
Changes in verbal fluency as measured with Controlled Oral Word Association Test.
Measured: Baseline and 6 months' follow-up
Verbal learning and memory
Changes in verbal learning and memory as measured with Hopkins Verbal Learning Test-Revised.
Measured: Baseline and 6 months' follow-up
Visuospatial learning and memory
Changes in visuospatial learning and memory as measured with WMS-III Visual Memory.
Measured: Baseline and 6 months' follow-up
Testosterone levels
Changes in testosterone levels as measured with liquid chromatography tandem mass spectrometry (LC-MS/MS).
Measured: Baseline and 6 months' follow-up
Brain grey matter
Changes in grey matter as measured with T1-weighted MRI.
Measured: Baseline and 6 months' follow-up
Brain white matter
Changes in brain white matter as measured with diffusion-weighted MRI.
Measured: Baseline and 6 months' follow-up
Moderator: APOE genotype
Genotype of the APOE gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphisms.
Measured: Baseline
Moderator: COMT genotype
Genotype of the COMT gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.
Measured: Baseline
Moderator: BDNF genotype
Genotype of the BDNF gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.
Measured: Baseline
Moderator: CAG repeat length of the AR gene
CAG repeat lenght of the AR gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.
Measured: Baseline
Neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition)
Changes in neurobehavioral symptoms as measured with The Frontal Systems Behavior Scale (FrsBe).
Measured: Baseline and 6 months' follow-up
Perceived cognitive functioning
Changes in perceived cognitive functioning as measured with The Patient Assessment of Own Functioning Inventory (POAFI).
Measured: Baseline and 6 months' follow-up
Health-related quality of life
Changes in health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life questionnaire for cancer patients (EORTC QLQ-C30).
Measured: Baseline and 6 months' follow-up
Health-related quality of life - Prostate Cancer
Changes in disease specific health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life Prostate Cancer Module (EORTC QLQ-PR25).
Measured: Baseline and 6 months' follow-up
Health-related quality of life - Testicular Cancer
Changes in disease specific health-related quality of life as measured with The European Organization for Research and Treatment of Cancer, Quality of Life Testicular Cancer Module (EORTC QLQ-TC25).
Measured: Baseline and 6 months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start12 Feb 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Cognitive ImpairmentStudies 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
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Cecilie D R Clausen, MSc, Principal investigator, Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus UniversityRobert Zachariae, Professor, DMSc, Study director, Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452436
- Sponsor's protocol ID
- TCAC
- Status last verified
- Apr 2019
- First submitted
- 1 Feb 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone, Cognition, Ageing, and Cancer - A Controlled, Prospective Study About the Association Between Testosterone and the Prevalence and Severity of Cancer Related Cognitive Impairment in Testicular and Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT03452436
- Acronym / sponsor ID
- TCAC
- Conditions
- Cancer-related Cognitive Impairment
- Keywords
- Cancer-related Cognitive Impairment, Cognitive Dysfunction, Cognition Disorders, Neurocognitive Disorder, Testosterone, Endocrinology, Testicular Cancer, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 Mar 2018 (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.
The primary aim of the study is - in a prospective controlled design - to examine whether treatment-induced decreases in testosterone acts as a mechanism of cancer-related cognitive impairment (CRCI) in testicular and prostate cancer patients.
Secondary aims are 1) to explore whether decreases in testosterone interacts with increasing age to cause more severe CRCI in older patients, 2) to explore underlying neurophysiological (brain morphology) mechanisms of CRCI, and 3) to evaluate selected genetic variants as possible moderators of CRCI.
Detailed description
The study will include three groups with a total of 120 participants: A) Forty testicular cancer patients will be included and examined 1) shortly after orchiectomy and prior to any further treatment and 2) at 6 months' follow- up. B) Forty prostate cancer patients will be included and examined at two time-points: 1) prior to initiation of medical castration and radiotherapy and 2) at 6 months' follow- up. C) Forty age- and education-matched healthy controls will be included and assessed at a similar time-interval, i.e., at an initial examination and at a 6 month follow-up. Measures include a battery of neuropsychological/ cognitive tests, questionnaires, blood samples, and Magnetic Resonance Imaging (MRI).
Primary hypothesis
- Treatment-induced decreases in testosterone will be associated with decline in global cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients. Secondary hypotheses
- Treatment-induced decreases in testosterone will be associated with decline in individual cognitive domains (i.e., processing speed, attention, verbal fluency, executive functioning, working memory, verbal learning and memory, visuospatial learning and memory, and visuospatial ability) from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
- Decline in cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients will correspond to changes in grey matter as measured by T1-weighted MRI.
- Decline in cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients will correspond to changes in brain white matter as measured with diffusion-weighted MRI.
- Treatment-induced decreases in testosterone will be more strongly associated with decline in cognitive functioning in prostate cancer patients compared with testicular cancer patients due to more advanced age in the former group.
- Treatment-induced decreases in testosterone will be more strongly associated with decline in cognitive functioning in both testicular and prostate cancer patients carrying the the Apolipoprotein E (APOE) ε4 allele, the Val catechol-O-methyltranferase (COMT) allele, the Val/Val Brain- derived neurotrophic factor (BDNF) genotype, and a short polymorphic CAG repeat length of the Androgen Receptor (AR) gene.
- Treatment-induced decreases in testosterone will be associated with increases in neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition) from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
- Treatment-induced decreases in testosterone will be associated with decreases in health-related quality of life from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
- Treatment-induced decreases in testosterone will be associated with decreases in perceived cognitive functioning from baseline to 6 months' follow- up in both testicular and prostate cancer patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Testicular cancer patients | – | –Forty testicular cancer patients included after orchiectomy but prior to any further treatment. |
| Prostate cancer patients | – | –Forty prostate cancer patients included prior to medical castration and radiotherapy. |
| Healthy controls | – | –Forty age- and education-matched healthy controls (20 matched to testicular cancer patients, 20 matched to prostate cancer patients). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men with testicular and prostate cancer seen at Aarhus University Hospital. Age- and education matched healthy controls recruited from the general population of Central Denmark Region.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of testicular cancer
- Confirmed diagnosis of prostate cancer and prescription of medical castration and radiotherapy
Key exclusion criteria (5 listed)
- Previous cancer disease
- Previous central nervous system disease
- Brain metastases
- Severe psychiatric disease (e.g., schizophrenia, major depressive disorder)
- Insufficient Danish proficiency for neuropsychological testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global cognitive functioning
Time frame: Baseline and 6 months' follow-up
Changes in global cognitive composite score as measured with neuropsychological tests specified under "Secondary Outcome Measures".
26 secondary outcomes
Visuospatial ability
Time frame: Baseline and 6 months' follow-up
Visuospatial ability
Time frame: Baseline and 6 months' follow-up
Visuospatial ability
Time frame: Baseline and 6 months' follow-up
Visuospatial ability
Time frame: Baseline and 6 months' follow-up
Processing speed
Time frame: Baseline and 6 months' follow-up
Processing speed
Time frame: Baseline and 6 months' follow-up
Attention
Time frame: Baseline and 6 months' follow-up
Executive functioning
Time frame: Baseline and 6 months' follow-up
Executive functioning
Time frame: Baseline and 6 months' follow-up
Working memory
Time frame: Baseline and 6 months' follow-up
Working memory
Time frame: Baseline and 6 months' follow-up
Verbal fluency
Time frame: Baseline and 6 months' follow-up
Verbal learning and memory
Time frame: Baseline and 6 months' follow-up
Visuospatial learning and memory
Time frame: Baseline and 6 months' follow-up
Testosterone levels
Time frame: Baseline and 6 months' follow-up
Brain grey matter
Time frame: Baseline and 6 months' follow-up
Brain white matter
Time frame: Baseline and 6 months' follow-up
Moderator: APOE genotype
Time frame: Baseline
Moderator: COMT genotype
Time frame: Baseline
Moderator: BDNF genotype
Time frame: Baseline
Moderator: CAG repeat length of the AR gene
Time frame: Baseline
Neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition)
Time frame: Baseline and 6 months' follow-up
Perceived cognitive functioning
Time frame: Baseline and 6 months' follow-up
Health-related quality of life
Time frame: Baseline and 6 months' follow-up
Health-related quality of life - Prostate Cancer
Time frame: Baseline and 6 months' follow-up
Health-related quality of life - Testicular Cancer
Time frame: Baseline and 6 months' follow-up
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 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Cecilie D R Clausen, MSc principal investigator
Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus University
Robert Zachariae, Professor, DMSc study director
Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus University
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 Cancer-related Cognitive Impairment, 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 2 inclusion and 5 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 25 Mar 2020. 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?
Global cognitive functioning (time frame: Baseline and 6 months' follow-up). 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 25 Mar 2020.