Testosterone, Cognition, Ageing, and Cancer
Mots clés
Abstrait
La 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.
Rendez-vous
| Dernière vérification: | 03/31/2019 |
| Première soumission: | 01/31/2018 |
| Inscription estimée soumise: | 02/28/2018 |
| Première publication: | 03/01/2018 |
| Dernière mise à jour soumise: | 03/23/2020 |
| Dernière mise à jour publiée: | 03/24/2020 |
| Date de début réelle de l'étude: | 02/11/2018 |
| Date d'achèvement primaire estimée: | 02/29/2020 |
| Date estimée d'achèvement de l'étude: | 02/29/2020 |
Condition ou maladie
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| 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). |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | Male |
| Méthode d'échantillonnage | Non-Probability Sample |
| Accepte les bénévoles en santé | Oui |
| Critères | 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 |
Résultat
Mesures des résultats primaires
1. Global cognitive functioning [Baseline and 6 months' follow-up]
Mesures des résultats secondaires
1. Visuospatial ability [Baseline and 6 months' follow-up]
2. Visuospatial ability [Baseline and 6 months' follow-up]
3. Visuospatial ability [Baseline and 6 months' follow-up]
4. Visuospatial ability [Baseline and 6 months' follow-up]
5. Processing speed [Baseline and 6 months' follow-up]
6. Processing speed [Baseline and 6 months' follow-up]
7. Attention [Baseline and 6 months' follow-up]
8. Executive functioning [Baseline and 6 months' follow-up]
9. Executive functioning [Baseline and 6 months' follow-up]
10. Working memory [Baseline and 6 months' follow-up]
11. Working memory [Baseline and 6 months' follow-up]
12. Verbal fluency [Baseline and 6 months' follow-up]
13. Verbal learning and memory [Baseline and 6 months' follow-up]
14. Visuospatial learning and memory [Baseline and 6 months' follow-up]
15. Testosterone levels [Baseline and 6 months' follow-up]
16. Brain grey matter [Baseline and 6 months' follow-up]
17. Brain white matter [Baseline and 6 months' follow-up]
18. Moderator: APOE genotype [Baseline]
19. Moderator: COMT genotype [Baseline]
20. Moderator: BDNF genotype [Baseline]
21. Moderator: CAG repeat length of the AR gene [Baseline]
22. Neurobehavioral symptoms (i.e., apathy, executive dysfunction, and disinhibition) [Baseline and 6 months' follow-up]
23. Perceived cognitive functioning [Baseline and 6 months' follow-up]
24. Health-related quality of life [Baseline and 6 months' follow-up]
25. Health-related quality of life - Prostate Cancer [Baseline and 6 months' follow-up]
26. Health-related quality of life - Testicular Cancer [Baseline and 6 months' follow-up]
