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

Recruiting

• Conditions: Prostate Cancer; Breast Cancer
• Interventions: Device: polysomnography, actigraphy, questionnaires

• Registration Number: NCT04543799
• Lead Sponsor: Oncology Institute of Southern Switzerland

Brief 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 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 Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-10
• Study Start: 2020-09-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
YET	polysomnography, actigraphy, questionnaires	Breast cancer survivors receiving endocrine therapy
NET	polysomnography, actigraphy, questionnaires	Breast cancer survivors not receiving endocrine therapy
A2	polysomnography, actigraphy, questionnaires	patients with localised prostate cancer receiving radiotherapy only
A1	polysomnography, actigraphy, questionnaires	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

Primary Outcome Measures

Name	Time	Method
difference in sleep quality	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

Trial Locations

Locations (1)

IOSI; 🇨🇭 Bellinzona, Switzerland