Sleep Disorders Trial, Recruiting NCT04543799 Sponsor: Oncology Institute of Southern Switzerland Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT04543799
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with prostate cancer:

  • Men aged 18 or older with prostate cancer that has been confirmed by a tissue sample (biopsy) showing a type called adenocarcinoma
  • People whose cancer is localised (contained in the prostate), locally advanced, or has spread to other parts of the body, but is still responding to hormone-reducing treatment
  • People who are generally well enough to carry out light activity or daily tasks (a standard fitness scale rated 0–2 is used to assess this)
  • People who are scheduled to receive hormone-reducing treatment (ADT) as standard care for more than 6 months, combined with radiotherapy, an oral hormone-targeting drug, or radiotherapy alone, as decided by their treating doctor
  • People who have signed a written consent form before any trial-related procedures begin

For people with breast cancer:

  • Women aged 18 or older who have had all detectable breast cancer surgically removed (stage I–III), including ductal carcinoma in situ or lobular carcinoma in situ, with no signs of remaining disease
  • Women who are confirmed to be postmenopausal (no menstrual period for at least 6 months, and/or a low oestrogen blood level, or who have had both ovaries removed or had ovarian function suppressed through radiation)
  • People who are generally well enough to carry out light activity or daily tasks (a standard fitness scale rated 0–2)
  • People who have signed a written consent form before any trial-related procedures begin

Who may not be able to join:

For people with prostate cancer:

  • People whose prostate cancer is mainly a type called small cell prostate cancer
  • People who have previously received hormone-reducing treatment (ADT) or an oral hormone-targeting drug (short-term anti-androgen use to prevent a disease flare may be an exception — confirm with trial site)
  • People who have received treatment for another cancer within the last 12 months
  • People who currently have another active cancer that requires ongoing systemic (whole-body) treatment
  • People for whom hormone-reducing treatment (ADT) is medically not suitable
  • People with a sleep breathing disorder (sleep apnoea) where breathing interruptions during sleep occur more than 15 times per hour
  • People with a body mass index (BMI) over 35
  • People with serious lung conditions such as severe asthma or severe chronic obstructive pulmonary disease (COPD)
  • People with serious heart disease, or who have had a serious heart-related event in the last 6 months
  • People who have had a stroke or other long-term neurological condition within the last 6 months
  • People with significantly reduced mental function or cognitive impairment
  • People with a history of brain tumours, cancer that has spread to the brain, or who have had radiation treatment to the head
  • People who work night shifts
  • People with habits that are known to significantly disrupt sleep, such as large amounts of coffee at night, or heavy smoking or alcohol use in the evening
  • People with poor sleep habits or an unhealthy sleep routine
  • People who need to urinate more than twice during the night on a regular basis
  • People currently diagnosed with depression or a psychiatric condition that is being treated with medication
  • People diagnosed with insomnia who regularly take sleeping medication
  • People who regularly take medications known to disturb sleep, such as older-generation antihistamines or cortisone at doses above 25 mg per day
  • People with any diagnosed condition that is known to cause sleep disturbance

For people with breast cancer:

  • People whose breast cancer is not the epithelial type, or is a mixed type containing non-epithelial cells
  • People who have previously received chemotherapy at any time, or who are taking hormone therapy at a non-standard dose
  • People who have received treatment for another cancer within the last 12 months
  • People who currently have another active cancer that requires ongoing systemic (whole-body) treatment
  • People with a sleep breathing disorder (sleep apnoea) where breathing interruptions during sleep occur more than 15 times per hour
  • People with a body mass index (BMI) over 35
  • People with serious lung conditions such as severe asthma or severe chronic obstructive pulmonary disease (COPD)
  • People with serious heart disease, or who have had a serious heart-related event in the last 6 months
  • People who have had a stroke or other long-term neurological condition within the last 6 months
  • People with significantly reduced mental function or cognitive impairment
  • People with a history of brain tumours, cancer that has spread to the brain, or who have had radiation treatment to the head
  • People who work night shifts
  • People with habits that are known to significantly disrupt sleep, such as large amounts of coffee at night, or heavy smoking or alcohol use in the evening
  • People with poor sleep habits or an unhealthy sleep routine
  • People who need to urinate more than twice during the night on a regular basis
  • People currently diagnosed with depression or a psychiatric condition that is being treated with medication
  • People diagnosed with insomnia who regularly take sleeping medication
  • People who regularly take medications known to disturb sleep, such as older-generation antihistamines or cortisone at doses above 25 mg per day, or who have any diagnosed condition known to cause sleep disturbance

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +419181113308463

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Oncology Institute of Southern Switzerland
Registry
ClinicalTrials.gov
Start date
24 September 2020
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇭 Switzerland

Primary endpoints

difference in sleep quality

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov