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

NCT04543799 | Recruiting

• 1 other identifier: SIESTA_01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• difference in sleep quality

  The two groups considered will be group A1, and group A2. This will demonstrate whether there is a difference in sleep quality between these two groups of patients. The difference between time points will establish correlation between treatment initiation and symptom onset, the between group analysis will test whether the link seems to be radiotherapy alone or whether ADT further decreases sleep quality

  1 year

Study Arms (4)

A1

Group A1 consists of patients with prostate cancer receiving ADT as part of their standard care for either locally advanced or metastatic disease. Group A1 consists of a combination of two groups; B1, metastatic patients receiving ADT both with and without an oral AR targeted agent, and not receiving radiotherapy and B2, locally advanced patients receiving ADT alongside radiotherapy

Device: polysomnography, actigraphy, questionnaires

A2

patients with localised prostate cancer receiving radiotherapy only

Device: polysomnography, actigraphy, questionnaires

YET

Breast cancer survivors receiving endocrine therapy

Device: polysomnography, actigraphy, questionnaires

NET

Breast cancer survivors not receiving endocrine therapy

Device: polysomnography, actigraphy, questionnaires

Interventions

polysomnography, actigraphy, questionnaires DEVICE

sleep quality recording

A1; A2; NET; YET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

i) Patients with localized, locally advanced or metastatic hormone-sensitive prostate cancer receiving standard of care treatment (including radiotherapy with or without androgen-deprivation treatment (ADT) or ADT alone +/- androgen receptor targeted agent) dependent on disease stage ii) Patients with full-resected early (stage I-III) epithelial BC, ductal carcinoma in situ or lobular carcinoma in situ, without evidence of residual disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead

Study Sites (1)

IOSI

Bellinzona, 6500, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms

Interventions

Polysomnography; Actigraphy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Ursula Vogl, MD

CONTACT

+419181113308463; ursula.vogl@eoc.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: September 24, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CH (1)