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

Launched by ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND · Sep 2, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how treatment for prostate cancer and early-stage breast cancer affects sleep quality. Specifically, it will look at patients who are starting hormonal therapies, such as androgen deprivation therapy for prostate cancer or endocrine therapy for breast cancer, to see if these treatments impact how well they sleep. Researchers will use various methods to measure sleep quality, including sleep studies, questionnaires, and saliva samples, at the beginning of treatment, after six months, and again at twelve months.

Eligible participants include men over 18 with hormone-sensitive prostate cancer and women over 18 who have had early-stage breast cancer that has been completely surgically removed. Participants will need to sign an informed consent form and meet certain health criteria. Throughout the trial, they can expect regular check-ins to assess their sleep quality and overall well-being. It's important to note that individuals with certain health issues or specific sleep disturbances may not be eligible to participate.

Gender

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Eligibility 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