Actively Recruiting
Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-01-28
53
Participants Needed
1
Research Sites
120 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
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.
CONDITIONS
Official 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
- Underwent 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 locoregional radiotherapy if 70 to 80 years old
- Right-sided invasive breast cancer with indication for locoregional radiotherapy
- Prior chemotherapy allowed
- Prior immunotherapy allowed
- Prior or concomitant hormonal therapy allowed
- Prior or concomitant HER2-targeted therapy allowed
You will not qualify if you...
- Active bullous lung disease, bypassed upper airway, pneumothorax, cerebral spinal fluid leaks, or cribriform plate abnormalities
- History of major head trauma or pneumocephalus
- Conditions that may risk participant safety or compliance
- Female who is pregnant, breastfeeding, or intends to become pregnant
- Male breast cancer patients
- Patients who underwent mastectomy
- Tumors located less than 28mm below breast surface requiring electron boost
- Patients requiring radiotherapy boost on positive lymph nodes
- Presence of distant metastasis
- Breast implants in place
- Right-sided in situ carcinoma
- Right-sided invasive breast cancer requiring only local radiotherapy without regional 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 area
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
A
Aline Van der Vorst, MD
CONTACT
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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