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

Reducing Cardiac Radiation Dose in Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer: a Prospective Non-Randomized Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• Intervention / Treatment: Device: Continuous Positive Airway Pressure (CPAP)

Detailed Description

Patients undergoing breast conserving surgery for invasive or in situ BC and requiring adjuvant RT are prospectively enrolled -either left-sided cases with or without regional nodal irradiation (RNI), or right-sided cases requiring RNI. Each patient undergoes an additional CT simulation with continuous positive airway pressure (CPAP) (15cm H20) -in free breathing (FB) for right-sided cases and in deep inspiration breath hold (DIBH) for left-sided cases. Left-sided patients unable to perform DIBH are evaluated in FB. Two RT plans (with and without CPAP) are dosimetrically compared. If CPAP reduces mean heart or CLB dose by ≥0.5 Gy, or mean lung dose by ≥1 Gy, treatment is delivered with CPAP. Patient comfort is assessed through surveys.

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Aline Van der Vorst, MD; Phone Number: +3216340115; Email: aline.vandervorst@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Aline Van der Vorst, MD; Phone Number: +3216340115; Email: aline.vandervorst@uzleuven.be
    • Contact: Email: caroline.weltens@uzleuven.be
    • Principal Investigator: Caroline Weltens, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. At least 40 years of age and 80 years or younger at the time of signing the Informed Consent Form (ICF)
3. Female patients
4. Patients that underwent breast conserving surgery (BCS)
5. Left-sided invasive BC / in situ carcinoma with indication for adjuvant RT (<70 years old)
6. Left-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes) (70-80 years old)
7. Right-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes)
8. Prior chemotherapy allowed
9. Prior immunotherapy allowed
10. Prior / concomitant hormonal therapy allowed
11. Prior / concomitant HER2-targeted therapy allowed

Exclusion Criteria:

1. 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)
2. Patient has history of major head trauma and/or pneumocephalus (contra-indications for the use of CPAP)
3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
4. Female who is pregnant, breast-feeding or intends to become pregnant (which is a contra-indication for RT in general)
5. Male BC patients
6. Patients that underwent mastectomy Patients whose initial tumor was located just beneath the skin (defined as being less than 28mm below the breast surface), indicating the need for an electron boost
7. Patients requiring RT boost on positive lymph nodes
8. Distant metastasis
9. Breast implants in situ
10. Right-sided in situ carcinoma
11. Right-sided invasive BC only requiring local adjuvant RT (without irradiation of the regional lymph nodes, because the presumed benefit on cardiac doses of local right-sided breast irradiation is assumed to be rather small because of the left anatomical position of the heart)
12. Bilateral BC
13. Concomitant use of chemotherapy during RT
14. Substantial comorbidities, incompatible with RT or CPAP use, estimated by the treating radiation oncologist
15. Insufficient arm mobility to perform comfortable arm positioning in radiation treatment position, evaluated by the treating radiation oncologist
16. Other active oncological disease / treatment with the exception of non-melanoma skin cancer
17. Previous RT with overlapping RT fields with actual target volume

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP-addition; CPAP is added to standard of care	Device: Continuous Positive Airway Pressure (CPAP); Positive airway pressure (15cmH2O) delivered by a CPAP-device
No Intervention: Standard of care; Right sided or 70 years or older: Free Breathing Left sided and younger than 70 years old: Deep Inspiration Breath Hold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean heart dose	Potential change of mean radiation dose to the heart	From enrollment to the end of treatment at +/-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doses to cardiac substructures	Potential change in radiation dose to cardiac substructures	From enrollment to the end of treatment at +/-8 weeks
Mean lung dose	Potential change in mean radiation dose to the lungs	From enrollment to the end of treatment at +/-8 weeks
Mean contralateral breast dose	Potential change in mean radiation dose to the contralateral breast	From enrollment to the end of treatment at +/-8 weeks
Liver dose	Potential change in radiation dose to the liver	From enrollment to the end of treatment at +/-8 weeks
Patient comfort	Patient comfort assessed through patient questionnaires (Likert scale: Strongly disagree - disagree - neutral - agree - strongly agree)	From enrollment to the end of treatment at +/-8 weeks
Reproducibility and accuracy of CPAP-assisted radiotherapy	Compare reproducibility and accuracy between standard and CPAP-assisted RT by using surface scanning and daily cone beam CT (CBCT) parameters	From enrollment to the end of treatment at +/-8 weeks
DIBH performance	To compare DIBH performance between standard and CPAP-assisted RT for left-sided BC by using surface scanning and daily CBCT parameters	From enrollment to the end of treatment at +/-8 weeks
Time-effectiveness	To compare time-effectiveness between standard and CPAP-assisted RT; Set-up time; Matching time; Radiation time	From enrollment to the end of treatment at +/-8 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: VitalAire

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; radiotherapy; toxicity; continuous positive airway pressure; dosimetry; cpap
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Microcephaly, Primary Autosomal Recessive, 6; Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID Numbers: S68702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No