Clinical Research Directory

Inclusion Criteria for prostate cancer patients: * 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 Exclusion Criteria for prostate cancer patients: * Histology with predominant small cell prostate cancer * Any previous treatment with ADT or oral AR-targeted agent (exception for short course anti-androgens - disease flare) * Have not received systemic treatment for any other cancer within the last 12 months * Active secondary malignancy that requires systemic therapy * Any clear contraindications present against treatment with ADT * Presence of sleep apnea syndrome, Apnea Hypopnea Index (AHI) \>15 at baseline * Body mass index (BMI) \> 35 at baseline * Severe respiratory disorders (asthma, Chronic obstructive pulmonary disease) at baseline * Severe cardiovascular disease or severe cardiovascular event \< 6 months * History of stroke or other neurologic chronic illnesses \< 6 months * Have demonstrated impaired mental status * History of brain tumours, presence of brain metastases or previous cranial irradiation * Night shift workers * Excessive lifestyle: massive coffee intake at night, regular excessive cigarette and alcohol consumption in the evening * Unhealthy sleep hygiene * Nocturia (the urgent need to urinate more than 2 times during the main sleep period at night) at baseline * Present diagnosis of depression or psychiatric illness pharmacologically treated * Diagnosis of insomnia and chronic intake of hypnotic medication at baseline * Chronic intake of medications that are known to induce sleep disturbance (antihistamines of first generation, cortisone intake \> 25 mg/day) * Any diagnosed condition that causes known sleep disturbance Inclusion criteria for breast cancer patients * 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) Exclusion criteria for breast cancer patients * Non-epithelial BC or BC with mixed epithelial and non-epithelial histology * Previous chemotherapy at any time, in treatment with ET at not standard dosage * Have received systemic treatment for any other cancer within the last 12 months * Active secondary malignancy that requires systemic therapy * Presence of sleep apnea syndrome, Apnea Hypopnea Index (AHI) \>15 at baseline * Body mass index (BMI) \> 35 at baseline * Severe respiratory disorders (asthma, Chronic obstructive pulmonary disease) at baseline * Severe cardiovascular disease or severe cardiovascular event \< 6 months * History of stroke or other neurologic chronic illnesses \< 6 months * Have demonstrated impaired mental status * History of brain tumours, presence of brain metastases or previous cranial irradiation * Night shift workers * Excessive lifestyle: massive coffee intake at night, regular excessive cigarette and alcohol consumption in the evening * Unhealthy sleep hygiene * Nocturia (the urgent need to urinate more than 2 times during the main sleep period at night) at baseline * Present diagnosis of depression or psychiatric illness pharmacologically treated * Diagnosis of insomnia and chronic intake of hypnotic medication at baseline * Chronic intake of medications that are known to induce sleep disturbance (antihistamines of first generation, cortisone intake \> 25 mg/day) or any diagnosed condition that causes known sleep disturbance