An observational study in Cancer-related Cognitive Impairment, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Aarhus · Observational
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.
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
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.
Exclusion Criteria:
Forty testicular cancer patients included after orchiectomy but prior to any further treatment.
Forty prostate cancer patients included prior to medical castration and radiotherapy.
Forty age- and education-matched healthy controls (20 matched to testicular cancer patients, 20 matched to prostate cancer patients).
Global cognitive functioning
Changes in global cognitive composite score as measured with neuropsychological tests specified under "Secondary Outcome Measures".
Time frame: Baseline and 6 months' follow-up
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Matrix Reasoning.
Time frame: Baseline and 6 months' follow-up
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Figure Weights.
Time frame: Baseline and 6 months' follow-up
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Visual Puzzles.
Time frame: Baseline and 6 months' follow-up
Visuospatial ability
Changes in visuospatial ability as measured with WAIS-IV Block Design.
Time frame: Baseline and 6 months' follow-up
Processing speed
Changes in processing speed as measured with Trail Making Test A.
Time frame: Baseline and 6 months' follow-up
Processing speed
Changes in processing speed as measured with WAIS-IV Coding.
Time frame: Baseline and 6 months' follow-up
Attention
Changes in attention as measured with WAIS-IV Digit Span Forwards.
Time frame: Baseline and 6 months' follow-up
Executive functioning
Changes in executive functioning as measured with Trail Making Test B.
Time frame: Baseline and 6 months' follow-up
Executive functioning
Changes in executive functioning as measured with Wisconsin Card Sorting Test.
Time frame: Baseline and 6 months' follow-up
Working memory
Changes in working memory as measured with WAIS-IV Digit Span Sequencing.
Time frame: Baseline and 6 months' follow-up
Working memory
Changes in working memory as measured with WAIS-IV Digit Span Backwards.
Time frame: Baseline and 6 months' follow-up
Verbal fluency
Changes in verbal fluency as measured with Controlled Oral Word Association Test.
Time frame: Baseline and 6 months' follow-up
Verbal learning and memory
Changes in verbal learning and memory as measured with Hopkins Verbal Learning Test-Revised.
Time frame: Baseline and 6 months' follow-up
Visuospatial learning and memory
Changes in visuospatial learning and memory as measured with WMS-III Visual Memory.
Time frame: Baseline and 6 months' follow-up
Testosterone levels
Changes in testosterone levels as measured with liquid chromatography tandem mass spectrometry (LC-MS/MS).
Time frame: Baseline and 6 months' follow-up
Brain grey matter
Changes in grey matter as measured with T1-weighted MRI.
Time frame: Baseline and 6 months' follow-up
Brain white matter
Changes in brain white matter as measured with diffusion-weighted MRI.
Time frame: Baseline and 6 months' follow-up
Moderator: APOE genotype
Genotype of the APOE gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphisms.
Time frame: Baseline
Moderator: COMT genotype
Genotype of the COMT gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.
Time frame: Baseline
Moderator: BDNF genotype
Genotype of the BDNF gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.
Time frame: 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.
Time frame: Baseline
Neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition)
Changes in neurobehavioral symptoms as measured with The Frontal Systems Behavior Scale (FrsBe).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and 6 months' follow-up
Plan to share: Undecided
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University of Aarhus