Evaluating sleep quality in prostate and breast cancer patients undergoing hormonal treatment
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 is trying to see how hormonal treatments affect sleep quality in people with prostate and breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oncology Institute of Southern Switzerland Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bellinzona) |
| Trial ID | NCT04543799 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess sleep quality in patients with localized, locally advanced, or metastatic hormone-sensitive prostate cancer and those with fully resected early-stage breast cancer. It will utilize polysomnography, questionnaires, actigraphy, and salivary melatonin samples to gather data on sleep patterns before and during hormonal therapies. Measurements will be taken at baseline, 6 months, and 12 months to compare sleep quality across different treatment groups. The study seeks to identify potential negative impacts of hormonal therapies on sleep and provide a foundation for future interventional trials.
Who should consider this trial
Good fit: Ideal candidates include adult males over 18 with hormone-sensitive prostate cancer scheduled for androgen deprivation therapy and patients with fully resected early-stage breast cancer.
Not a fit: Patients with small cell prostate cancer or those not scheduled for hormonal therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of sleep quality in cancer patients undergoing hormonal treatments.
How similar studies have performed: While this approach is novel in its methodology, previous studies have indicated that hormonal treatments can affect sleep quality, suggesting potential relevance.
Eligibility criteria
Show full inclusion / exclusion 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 (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 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 \< 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 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 \<40 pg/ml, or bilateral oophorectomy or ovarian irradiation for suppression of ovarian function) Exclusion criteria for breast cancer patients * 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
Where this trial is running
Bellinzona
- Iosi — Bellinzona, Switzerland (Recruiting)
Study contacts
- Study coordinator: Ursula Vogl, MD
- Email: ursula.vogl@eoc.ch
- Phone: +419181113308463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.