RecruitingNCT04543799

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

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

Sponsor

Oncology Institute of Southern Switzerland

Enrollment

60 participants

Start Date

Sep 24, 2020

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Prostate Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria38

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
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