Actively Recruiting

Age: 18Years +
All Genders
NCT04543799

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

Led by Oncology Institute of Southern Switzerland · Updated on 2025-11-18

60

Participants Needed

1

Research Sites

327 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) regulations before registration
  • Histologically proven adenocarcinoma of the prostate for prostate cancer patients
  • Eastern Cooperative Oncology Group performance status 0-2
  • Adult male patient over 18 years, no upper age limit, with localized, locally advanced hormone-sensitive or metastatic hormone-sensitive prostate cancer
  • Scheduled to start androgen deprivation therapy as standard of care for at least 6 months
  • Women with full-resected early (stage I-III) epithelial breast cancer, ductal carcinoma in situ or lobular carcinoma in situ, without residual disease
  • Adult female patient 18 years or older with proven postmenopausal status defined by absence of menstruation for at least 6 months or specific hormonal/ovarian criteria
  • Eastern Cooperative Oncology Group performance status 0-2
Not Eligible

You will not qualify if you...

  • Histology with predominant small cell prostate cancer
  • Previous treatment with androgen deprivation therapy or oral AR-targeted agents (except short course anti-androgens)
  • Systemic treatment for any other cancer within the last 12 months
  • Active secondary malignancy requiring systemic therapy
  • Contraindications against androgen deprivation therapy
  • Presence of sleep apnea syndrome with Apnea Hypopnea Index over 15 at baseline
  • Body mass index over 35 at baseline
  • Severe respiratory disorders such as asthma or chronic obstructive pulmonary disease
  • Severe cardiovascular disease or cardiovascular events within the last 6 months
  • History of stroke or other neurologic chronic illnesses within the last 6 months
  • Impaired mental status
  • History of brain tumors, brain metastases, or previous cranial irradiation
  • Night shift workers
  • Excessive lifestyle habits including massive coffee intake at night or regular heavy cigarette and alcohol use in the evening
  • Unhealthy sleep hygiene
  • Nocturia with urgent urination more than twice during main sleep period at baseline
  • Present diagnosis of depression or psychiatric illness under pharmacological treatment
  • Diagnosis of insomnia with chronic hypnotic medication use at baseline
  • Chronic intake of medications known to cause sleep disturbance such as first-generation antihistamines or cortisone over 25 mg/day
  • Any diagnosed condition causing known sleep disturbance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

IOSI

Bellinzona, Switzerland, 6500

Actively Recruiting

Loading map...

Research Team

U

Ursula Vogl, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here