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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04543799

Studienbeginn:
September 2020

Letztes Update:
28.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms, Prostatic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Oncology Institute of Southern Switzerland

Collaborator:
-

Kontakt

Ursula Vogl, MD
Kontakt:
Phone: +419181113308463
E-Mail: ursula.vogl@eoc.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

IOSI
6500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Ursula Vogl
Phone: +4198118463
E-Mail: ursula.vogl@eoc.ch» Ansprechpartner anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. difference in sleep quality (Time Frame - 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

Studien-Arme

A1
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
A2
patients with localised prostate cancer receiving radiotherapy only
YET
Breast cancer survivors receiving endocrine therapy
NET
Breast cancer survivors not receiving endocrine therapy

Geprüfte Regime

polysomnography, actigraphy, questionnaires:
sleep quality recording

Quelle: ClinicalTrials.gov

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