Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age40-80
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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
Qualifiers
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
At least 40 years of age and 80 years or younger at the time of signing the Informed Consent Form (ICF)
Female patients
Patients that underwent breast conserving surgery (BCS)
Disqualifiers
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)
Patient has history of major head trauma and/or pneumocephalus (contra-indications for the use of CPAP)
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
Female who is pregnant, breast-feeding or intends to become pregnant (which is a contra-indication for RT in general)
Trial design
Treatments tested in this trial
- Continuous Positive Airway Pressure (CPAP)
Treatment groups
53 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
VitalAire
Collaborator
Source ClinicalTrials.gov