Breathing device may shield heart during breast cancer radiation
NCT ID NCT07373782
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a CPAP breathing mask during radiation therapy for early-stage breast cancer can lower radiation doses to the heart and lungs. About 53 women with left-sided breast cancer will receive radiation with CPAP support. The goal is to reduce long-term heart and lung side effects without changing cancer treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 40 years of age and 80 years or younger at the time of signing the Informed Consent Form (ICF) 3. Female patients 4. Patients that underwent breast conserving surgery (BCS) 5. Left-sided invasive BC / in situ carcinoma with indication for adjuvant RT (\<70 years old) 6. Left-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes) (70-80 years old) 7. Right-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes) 8. Prior chemotherapy allowed 9. Prior immunotherapy allowed 10. Prior / concomitant hormonal therapy allowed 11. Prior / concomitant HER2-targeted therapy allowed Exclusion Criteria: 1. 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) 2. Patient has history of major head trauma and/or pneumocephalus (contra-indications for the use of CPAP) 3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP. 4. Female who is pregnant, breast-feeding or intends to become pregnant (which is a contra-indication for RT in general) 5. Male BC patients 6. 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 7. Patients requiring RT boost on positive lymph nodes 8. Distant metastasis 9. Breast implants in situ 10. Right-sided in situ carcinoma 11. Right-sided invasive BC only requiring local adjuvant RT (without irradiation of the regional lymph nodes, because the presumed benefit on cardiac doses of local right-sided breast irradiation is assumed to be rather small because of the left anatomical position of the heart) 12. Bilateral BC 13. Concomitant use of chemotherapy during RT 14. Substantial comorbidities, incompatible with RT or CPAP use, estimated by the treating radiation oncologist 15. Insufficient arm mobility to perform comfortable arm positioning in radiation treatment position, evaluated by the treating radiation oncologist 16. Other active oncological disease / treatment with the exception of non-melanoma skin cancer 17. Previous RT with overlapping RT fields with actual target volume
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could fewer heart tests be safer for breast cancer patients?