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Trial record 47 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Testicular Neoplasms"

Testosterone, Cognition, Ageing, and Cancer

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ClinicalTrials.gov Identifier: NCT03452436
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

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.


Condition or disease
Cancer-related Cognitive Impairment

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

  1. 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

  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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 Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
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).



Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. Visuospatial ability [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in visuospatial ability as measured with WAIS-IV Matrix Reasoning.

  2. Visuospatial ability [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in visuospatial ability as measured with WAIS-IV Figure Weights.

  3. Visuospatial ability [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in visuospatial ability as measured with WAIS-IV Visual Puzzles.

  4. Visuospatial ability [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in visuospatial ability as measured with WAIS-IV Block Design.

  5. Processing speed [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in processing speed as measured with Trail Making Test A.

  6. Processing speed [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in processing speed as measured with WAIS-IV Coding.

  7. Attention [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in attention as measured with WAIS-IV Digit Span Forwards.

  8. Executive functioning [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in executive functioning as measured with Trail Making Test B.

  9. Executive functioning [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in executive functioning as measured with Wisconsin Card Sorting Test.

  10. Working memory [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in working memory as measured with WAIS-IV Digit Span Sequencing.

  11. Working memory [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in working memory as measured with WAIS-IV Digit Span Backwards.

  12. Verbal fluency [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in verbal fluency as measured with Controlled Oral Word Association Test.

  13. Verbal learning and memory [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in verbal learning and memory as measured with Hopkins Verbal Learning Test-Revised.

  14. Visuospatial learning and memory [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in visuospatial learning and memory as measured with WMS-III Visual Memory.

  15. Testosterone levels [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in testosterone levels as measured with liquid chromatography tandem mass spectrometry (LC-MS/MS).

  16. Brain grey matter [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in grey matter as measured with T1-weighted MRI.

  17. Brain white matter [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in brain white matter as measured with diffusion-weighted MRI.

  18. Moderator: APOE genotype [ Time Frame: Baseline ]
    Genotype of the APOE gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphisms.

  19. Moderator: COMT genotype [ Time Frame: Baseline ]
    Genotype of the COMT gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.

  20. Moderator: BDNF genotype [ Time Frame: Baseline ]
    Genotype of the BDNF gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.

  21. Moderator: CAG repeat length of the AR gene [ Time Frame: Baseline ]
    CAG repeat lenght of the AR gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.

  22. Neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition) [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in neurobehavioral symptoms as measured with The Frontal Systems Behavior Scale (FrsBe).

  23. Perceived cognitive functioning [ Time Frame: Baseline and 6 months' follow-up ]
    Changes in perceived cognitive functioning as measured with The Patient Assessment of Own Functioning Inventory (POAFI).

  24. Health-related quality of life [ Time Frame: Baseline and 6 months' follow-up ]
    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).

  25. Health-related quality of life - Prostate Cancer [ Time Frame: Baseline and 6 months' follow-up ]
    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).

  26. Health-related quality of life - Testicular Cancer [ Time Frame: Baseline and 6 months' follow-up ]
    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).


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of testicular cancer
  • Confirmed diagnosis of prostate cancer and prescription of medical castration and radiotherapy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452436


Contacts
Contact: Cecilie D R Clausen, MSc 0045 87165074 cdrc@psy.au.dk
Contact: Robert Zachariae, Professor, DMSc 0045 87165878 bzach@aarhus.rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Cecilie D R Clausen, MSc    0045 60185099    cdrc@psy.au.dk   
Contact: Robert Zachariae, Professor, DMSc    0045 871 65878    bzach@aarhus.rm.dk   
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Cecilie D R Clausen, MSc Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus University
Study Director: Robert Zachariae, Professor, DMSc Unit for Psychooncology & Health Psychology, Department of Oncology, Aarhus University

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03452436     History of Changes
Other Study ID Numbers: TCAC
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Cancer-related Cognitive Impairment
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorder
Testosterone
Endocrinology
Testicular Cancer
Prostate Cancer

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents