Actively Recruiting
Reducing Cardiac Radiation Dose in Continuous Positive Airway Pressure Assisted Radiotherapy for Breast Cancer: A Prospective Non-Randomized Clinical Trial
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-01-28
53
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
V
VitalAire
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the potential benefits of using continuous positive airway pressure (CPAP) during radiotherapy for patients with early stage breast cancer who have had breast conserving surgery. The study aims to see if CPAP can reduce radiation exposure to the heart and lungs compared to standard radiotherapy. This may help lower the risk of radiation-related heart and lung problems over time. The study also explores how CPAP can be integrated into daily radiotherapy practice. Participants include women aged 40 to 80 who have invasive or in situ breast cancer requiring radiotherapy. Each patient undergoes CT simulations with and without CPAP support. For left-sided breast cancer patients under 70, a deep inspiration breath hold technique is used, while right-sided cases and patients 70 or older use free breathing. If CPAP reduces radiation doses to the heart or lungs significantly, treatment is given with CPAP. Comfort and treatment accuracy with CPAP are also assessed. During the study, heart and lung radiation doses are closely monitored from enrollment until about eight weeks after treatment ends. Researchers evaluate patient comfort through surveys and check how well CPAP-assisted radiotherapy can be reproduced and delivered accurately. They also measure radiation doses to other areas like the contralateral breast and liver, assess breath hold performance, and study the time-effectiveness of CPAP use. Total participation spans the radiotherapy period plus follow-up assessments.
CONDITIONS
Brief Title
Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening
- Female patients aged 40 to 80 years
- Patients who had breast conserving surgery
- Left-sided invasive or in situ breast cancer with indication for adjuvant radiotherapy if under 70 years old
- Left-sided invasive breast cancer with indication for adjuvant locoregional radiotherapy including lymph nodes if aged 70 to 80 years
- Right-sided invasive breast cancer with indication for adjuvant locoregional radiotherapy including lymph nodes
- Prior chemotherapy allowed
- Prior immunotherapy allowed
- Prior or concurrent hormonal therapy allowed
- Prior or concurrent HER2-targeted therapy allowed
You will not qualify if you...
- Active bullous lung disease, bypassed upper airway, pneumothorax, cerebrospinal fluid leaks, or cribriform plate abnormalities
- History of major head trauma or pneumocephalus
- Any disorder risking safety or compliance with the study
- Pregnancy, breastfeeding, or intent to become pregnant
- Male breast cancer patients
- Patients who had mastectomy
- Tumor located less than 28 mm below breast surface requiring electron boost
- Need for radiotherapy boost on positive lymph nodes
- Distant metastasis
- Presence of breast implants
- Right-sided in situ carcinoma
- Right-sided invasive breast cancer requiring only local radiotherapy without lymph node irradiation
- Bilateral breast cancer
- Concurrent chemotherapy during radiotherapy
- Significant comorbidities incompatible with radiotherapy or CPAP
- Insufficient arm mobility for treatment positioning
- Other active cancer treatments except non-melanoma skin cancer
- Previous radiotherapy overlapping current target volume fields
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants undergo CT simulation with and without CPAP to compare radiotherapy plans. If CPAP reduces radiation dose to the heart, lung, or contralateral breast, they receive radiotherapy using CPAP.
Multiple visits for CT simulations and radiotherapy sessions over approximately 8 weeks
Duration - Up to 8 weeks from enrollment to end of treatment
Participants complete patient comfort surveys and assessments on reproducibility, accuracy, and performance of CPAP-assisted radiotherapy.
Periodic assessments during treatment duration
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
A
Aline Van der Vorst, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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