NCT04543799

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Oncology Institute of Southern Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Prostate Cancer
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	polysomnography, actigraphy, questionnaires	sleep quality recording

Timeline

• Start date: 2020-09-24
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-09-10
• Last updated: 2025-11-18

Locations

1 site across 1 country: Switzerland