NCT07373782 Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer
| NCT ID | NCT07373782 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 53 participants in total. It began in 2025-02-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07373782 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 80 Years, studying Breast Cancer Early Stage Breast Cancer (Stage 1-3). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07373782 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07373782 currently recruiting?
Yes, NCT07373782 is actively recruiting participants. Contact the research team at aline.vandervorst@uzleuven.be for enrollment information.
Where is the NCT07373782 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07373782 clinical trial?
NCT07373782 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 53 participants.
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