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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOncology Institute of Southern Switzerland

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • polysomnography, actigraphy, questionnaires

Treatment groups

60 Participants
are divided into 4 treatment groups