Evaluation of Sleep Quality in Prostate Cancer Patients Undergoing Treatment With Hormonal Therapeutic Approaches and in Patients With Full-resected Early Breast Cancer

The main outcomes of this pilot study can be summarised as:

• Using a previously unused methodology to assess whether ADT / endocrine therapy may negatively affect patterns of sleep quality
• Identifying sleep micro/macrostructure changes in prostate cancer patients receiving ADT / endocrine therapy
• Comparing the novel methodology with results obtained previously through standard methods
• Providing statistical underpinnings, such as sample size calculations, for a full interventional trial
• Highlighting the most appropriate non-pharmaceutical interventions to be tested in the full interventional trial

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