Sleep quality in people with prostate or breast cancer on hormone treatment

Trial details

Who runs it

Oncology Institute of Southern Switzerland

Trial code

NCT04543799

Record updated

18 November 2025

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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).

Exclusion: 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; Any clear contraindications present against treatment with ADT; History of brain tumours, presence of brain metastases or previous cranial irradiation; 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); 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; History of brain tumours, presence of brain metastases or previous cranial irradiation; Diagnosis of insomnia and chronic intake of hypnotic medication at baseline; Histology with predominant small cell prostate cancer; Active secondary malignancy that requires systemic therapy; Presence of sleep apnea syndrome, Apnea Hypopnea Index (AHI) >15 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; Present diagnosis of depression or psychiatric illness pharmacologically treated; Any diagnosed condition that causes known sleep disturbance; Active secondary malignancy that requires systemic therapy; Presence of sleep apnea syndrome, Apnea Hypopnea Index (AHI) >15 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; Present diagnosis of depression or psychiatric illness pharmacologically treated; 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; Body mass index (BMI) > 35 at baseline; Have demonstrated impaired mental status; 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; Non-epithelial BC or BC with mixed epithelial and non-epithelial histology; Body mass index (BMI) > 35 at baseline; Have demonstrated impaired mental status; 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.

ClinicalTrials.gov NCT04543799