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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

About This Trial

This study looks at how hormone therapy affects sleep quality over time in people with prostate cancer.
It is open to men who are about to start hormone therapy for the first time and will receive it for at least six months.
Participants will have their sleep monitored before treatment begins and again at six and twelve months using wearable activity trackers, overnight sleep tests, questionnaires, and saliva samples.
Before considering this study, you should know that you may not be eligible if you already have serious sleep issues—such as sleep apnea or insomnia—frequently wake up more than twice a night to urinate, or work night shifts.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: All
Who This Trial is For: This study looks at how hormone therapy affects sleep quality over time in people with prostate cancer.

Study Details

Start Date: September 24, 2020
Lead Sponsor: Oncology Institute of Southern Switzerland

Full Eligibility Criteria

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 (Standard of Care) for metastatic or locally advanced prostate cancer
Scheduled to receive ADT treatment as Standard of Care 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 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 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 25 mg/day) or any diagnosed condition that causes known sleep disturbance