Clinical Trial

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

Study acronym: SIESTA
Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-09-02; most recent amendment 2025-11-14.
Status change: Not Yet Recruiting → Recruiting 2023-04-24
Trial Details
NCT Number NCT04543799
Lead Sponsor Oncology Institute of Southern Switzerland
Conditions Prostate Cancer, Breast Cancer
Enrollment 60 participants
Start Date 2020-09-24
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-18