Testosterone, Cognition, Ageing, and Cancer

March 24, 2020 updated by: University of Aarhus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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".
Baseline and 6 months' follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visuospatial ability
Time Frame: Baseline and 6 months' follow-up
Changes in visuospatial ability as measured with WAIS-IV Matrix Reasoning.
Baseline and 6 months' follow-up
Visuospatial ability
Time Frame: Baseline and 6 months' follow-up
Changes in visuospatial ability as measured with WAIS-IV Figure Weights.
Baseline and 6 months' follow-up
Visuospatial ability
Time Frame: Baseline and 6 months' follow-up
Changes in visuospatial ability as measured with WAIS-IV Visual Puzzles.
Baseline and 6 months' follow-up
Visuospatial ability
Time Frame: Baseline and 6 months' follow-up
Changes in visuospatial ability as measured with WAIS-IV Block Design.
Baseline and 6 months' follow-up
Processing speed
Time Frame: Baseline and 6 months' follow-up
Changes in processing speed as measured with Trail Making Test A.
Baseline and 6 months' follow-up
Processing speed
Time Frame: Baseline and 6 months' follow-up
Changes in processing speed as measured with WAIS-IV Coding.
Baseline and 6 months' follow-up
Attention
Time Frame: Baseline and 6 months' follow-up
Changes in attention as measured with WAIS-IV Digit Span Forwards.
Baseline and 6 months' follow-up
Executive functioning
Time Frame: Baseline and 6 months' follow-up
Changes in executive functioning as measured with Trail Making Test B.
Baseline and 6 months' follow-up
Executive functioning
Time Frame: Baseline and 6 months' follow-up
Changes in executive functioning as measured with Wisconsin Card Sorting Test.
Baseline and 6 months' follow-up
Working memory
Time Frame: Baseline and 6 months' follow-up
Changes in working memory as measured with WAIS-IV Digit Span Sequencing.
Baseline and 6 months' follow-up
Working memory
Time Frame: Baseline and 6 months' follow-up
Changes in working memory as measured with WAIS-IV Digit Span Backwards.
Baseline and 6 months' follow-up
Verbal fluency
Time Frame: Baseline and 6 months' follow-up
Changes in verbal fluency as measured with Controlled Oral Word Association Test.
Baseline and 6 months' follow-up
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.
Baseline and 6 months' follow-up
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.
Baseline and 6 months' follow-up
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).
Baseline and 6 months' follow-up
Brain grey matter
Time Frame: Baseline and 6 months' follow-up
Changes in grey matter as measured with T1-weighted MRI.
Baseline and 6 months' follow-up
Brain white matter
Time Frame: Baseline and 6 months' follow-up
Changes in brain white matter as measured with diffusion-weighted MRI.
Baseline and 6 months' follow-up
Moderator: APOE genotype
Time Frame: Baseline
Genotype of the APOE gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphisms.
Baseline
Moderator: COMT genotype
Time Frame: Baseline
Genotype of the COMT gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.
Baseline
Moderator: BDNF genotype
Time Frame: Baseline
Genotype of the BDNF gene obtained by TaqMan-genotyping the appropriate single nucleotide polymorphism.
Baseline
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.
Baseline
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).
Baseline and 6 months' follow-up
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).
Baseline and 6 months' follow-up
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).
Baseline and 6 months' follow-up
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).
Baseline and 6 months' follow-up
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).
Baseline and 6 months' follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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