Continuous positive airway pressure in breast cancer radiotherapy: Protocol of a prospective clinical trial.
A Van der Vorst, J Verhoeven, A Baten...
https://pubmed.ncbi.nlm.nih.gov/42305413/Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-01-28
53
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer
A
Aline Van der Vorst, MD
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Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
VitalAire
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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A Van der Vorst, J Verhoeven, A Baten...
https://pubmed.ncbi.nlm.nih.gov/42305413/Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
VitalAire
Collaborating Sponsor