SIESTA: A Pilot Observational Study to Investigate and Evaluate Sleep Quality in Cancer Patients Undergoing Hormonal Therapeutic Approaches: 1) Localized, Locally Advanced or Metastatic Prostate Cancer Receiving Treatment Including Androgen Deprivation Therapy 2) Full-resected Early (Stage I-III) Breast Cancer, Ductal Carcinoma in Situ or Lobular Carcinoma in Situ, Without Evidence of Residual Disease; Proven Postmenopausal Status
This study will use polysomnography, alongside other methodologies such as questionnaires, actigraphic measurements and salivary melatonin samples used in previous studies to investigate sleep quality in patients with i) localized, locally advanced or metastatic hormone sensitive prostate cancer or ii) with full-resected early (stage I-III) epithelial breast cancer. The measurements will be taken before androgen deprivation therapy (ADT - for prostate cancer patients) or endocrine therapy (for breast cancer patients) is initiated, at 6 months and some measures again at 12 months.The groups, defined by cancer type and whether or not treatment includes ADT / endocrine therapy, will be compared to see if there are differences in the prevalence of the lowered sleep quality in the groups.
• Written infor med consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures
• Histologically proven adenocarcinoma of the prostate
• Eastern Cooperative Oncology Group performance status 0-2
• Adult male patient \> 18 years of age, no upper age limit
• Localized prostate cancer, locally advanced hormone-sensitive prostate cancer (HSPC) or metastatic hormone-sensitive prostate cancer (mHSPC)
• ADT recipients are required to be scheduled to start ADT as standard of care (SOC) for metastatic or locally advanced prostate cancer
• Scheduled to receive ADT treatment as SOC for \> 6 months in combination with radiotherapy or oral AR-targeted systemic treatment as prescribed by the treating physician or radiotherapy alone
• Written informed consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures
• Women with full-resected early (stage I-III) epithelial BC, ductal carcinoma in situ or lobular carcinoma in situ, without evidence of residual disease
• Eastern Cooperative Oncology Group performance status 0-2
• Adult female patient ≥ 18 years of age, no upper age limit
• Proven postmenopausal status (defined by absence of menstruation for at least 6 months and/or level of estradiol \<40 pg/ml, or bilateral oophorectomy or ovarian irradiation for suppression of ovarian function)