Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer (NCT07373782) | Clinical Trial Compass
RecruitingPhase 2/3
Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer
Belgium53 participantsStarted 2025-02-11
Plain-language summary
This study is a prospective, non-randomized clinical study aimed at investigating the potential benefits of continuous positive airway pressure (CPAP) support during radiotherapy for breast cancer. CPAP is a device commonly used to support breathing, for example in patients with sleep apnea. The investigators expect a reduction in radiation doses to the heart and/or lungs with CPAP-supported radiotherapy compared to standard radiotherapy (without CPAP), which may also lead to a decrease in radiation-induced heart and/or lung conditions in the long term. The study will also examine how the use of a CPAP device can be implemented in daily radiotherapy practice.
Who can participate
Age range
40 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
. At least 40 years of age and 80 years or younger at the time of signing the Informed Consent Form (ICF)
. Female patients
. Patients that underwent breast conserving surgery (BCS)
. Left-sided invasive BC / in situ carcinoma with indication for adjuvant RT (\<70 years old)
. Left-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes) (70-80 years old)
. Right-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean heart dose
Timeframe: From enrollment to the end of treatment at +/-8 weeks
. Patient has active bullous lung disease, bypassed upper airway, pneumothorax, cerebral spinal fluid leaks, abnormalities of the cribriform plate (contra-indications for the use of CPAP)
. Patient has history of major head trauma and/or pneumocephalus (contra-indications for the use of CPAP)
. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
. Female who is pregnant, breast-feeding or intends to become pregnant (which is a contra-indication for RT in general)
. Male BC patients
. Patients that underwent mastectomy Patients whose initial tumor was located just beneath the skin (defined as being less than 28mm below the breast surface), indicating the need for an electron boost
. Patients requiring RT boost on positive lymph nodes