Prostate CancerSIESTANCT04543799
Evaluation of Sleep Quality in Prostate Cancer Patients Undergoing Treatment With Hormonal Therapeutic Approaches and in Patients With Full-resected Early Breast Cancer
An observational study of Prostate Cancer and Breast Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer
- What is being tested?
- polysomnography, actigraphy, questionnaires
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Sep 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 38Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
IOSI
Bellinzona, 6500
Ursula Vogl, +4198118463, ursula.vogl@eoc.ch
About this study
Official title: 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
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.
Read the 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
- Being tested
- polysomnography, actigraphy, questionnaires
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnography, actigraphy, questionnairesDevice
sleep quality recording
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: polysomnography, actigraphy, questionnaires | |
| A2 | patients with localised prostate cancer receiving radiotherapy only Receives: Device: polysomnography, actigraphy, questionnaires | |
| YET | Breast cancer survivors receiving endocrine therapy Receives: Device: polysomnography, actigraphy, questionnaires | |
| NET | Breast cancer survivors not receiving endocrine therapy Receives: Device: polysomnography, actigraphy, questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start24 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543799
- Sponsor's protocol ID
- SIESTA_01
- Acronym
- SIESTA
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04543799
- Acronym / sponsor ID
- SIESTA / SIESTA_01
- Conditions
- Prostate Cancer, Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | – | Device: polysomnography, actigraphy, questionnairesGroup 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 |
| A2 | – | Device: polysomnography, actigraphy, questionnairespatients with localised prostate cancer receiving radiotherapy only |
| YET | – | Device: polysomnography, actigraphy, questionnairesBreast cancer survivors receiving endocrine therapy |
| NET | – | Device: polysomnography, actigraphy, questionnairesBreast cancer survivors not receiving endocrine therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polysomnography, actigraphy, questionnairessleep quality recording | Device | A1, A2, NET, YET |
Primary outcome
difference in sleep quality
Time frame: 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Breast Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ursula Vogl, MD (+419181113308463, ursula.vogl@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in sleep quality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.