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 |
Trial Parameters
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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, abnorma
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