Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Continuous Positive Airway Pressure (CPAP)
Device
Positive airway pressure (15cmH2O) delivered by a CPAP-device

Treatment groups

53 Participants

are divided into 2 treatment groups

Group A: CPAP-additionExperimental treatment 1 intervention

Group B: Standard of careNo intervention 0 interventions

Trial outcomes