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Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 2/3NCT07373782

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

A Phase 2/3 study testing Continuous Positive Airway Pressure (CPAP) in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 80 years, women only
What is being tested?
Continuous Positive Airway Pressure (CPAP)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteBelgium
Study dates
11 Feb 2025to Jun 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Left-sided invasive BC / in situ carcinoma with indication for adjuvant RT (<70 years old)
  • Left-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes) (70-80 years old)
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  • Right-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes)
  • Prior chemotherapy allowed
  • Prior immunotherapy allowed
  • Prior / concomitant hormonal therapy allowed
  • Prior / concomitant HER2-targeted therapy allowed

Who cannot join

  • 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)
  • Male BC patients
  • 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
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  • Patients requiring RT boost on positive lymph nodes
  • Distant metastasis
  • Breast implants in situ
  • Right-sided in situ carcinoma
  • 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)
  • Bilateral BC
  • Concomitant use of chemotherapy during RT
  • Substantial comorbidities, incompatible with RT or CPAP use, estimated by the treating radiation oncologist
  • Insufficient arm mobility to perform comfortable arm positioning in radiation treatment position, evaluated by the treating radiation oncologist
  • Other active oncological disease / treatment with the exception of non-melanoma skin cancer
  • Previous RT with overlapping RT fields with actual target volume

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aline Van der Vorst, MD contact

+3216340115

aline.vandervorst@uzleuven.be

Belgium1 site, 1 recruiting

  • UZ Leuven

    Leuven, 3000

    Aline Van der Vorst, MD, +3216340115, aline.vandervorst@uzleuven.be

    caroline.weltens@uzleuven.be

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Continuous Positive Airway Pressure (CPAP)
Keywords
breast cancer, radiotherapy, cpap, continuous positive airway pressure, dosimetry, toxicity
Medical subject headings
Breast Neoplasms, Microcephaly, Primary Autosomal Recessive, 6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Positive Airway Pressure (CPAP)Device

    Positive airway pressure (15cmH2O) delivered by a CPAP-device

Study groups in NCT07373782
Study groupRoleWhat they receive
CPAP-additionExperimentalCPAP is added to standard of care
Receives: Device: Continuous Positive Airway Pressure (CPAP)
Standard of careNo interventionRight sided or 70 years or older: Free Breathing Left sided and younger than 70 years old: Deep Inspiration Breath Hold

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean heart dose

    Potential change of mean radiation dose to the heart

    Measured: From enrollment to the end of treatment at +/-8 weeks

Secondary outcomes (8)

  1. Doses to cardiac substructures

    Potential change in radiation dose to cardiac substructures

    Measured: From enrollment to the end of treatment at +/-8 weeks

  2. Mean lung dose

    Potential change in mean radiation dose to the lungs

    Measured: From enrollment to the end of treatment at +/-8 weeks

  3. Mean contralateral breast dose

    Potential change in mean radiation dose to the contralateral breast

    Measured: From enrollment to the end of treatment at +/-8 weeks

  4. Liver dose

    Potential change in radiation dose to the liver

    Measured: From enrollment to the end of treatment at +/-8 weeks

  5. Patient comfort

    Patient comfort assessed through patient questionnaires (Likert scale: Strongly disagree - disagree - neutral - agree - strongly agree)

    Measured: From enrollment to the end of treatment at +/-8 weeks

  6. 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

    Measured: From enrollment to the end of treatment at +/-8 weeks

  7. DIBH performance

    To compare DIBH performance between standard and CPAP-assisted RT for left-sided BC by using surface scanning and daily CBCT parameters

    Measured: From enrollment to the end of treatment at +/-8 weeks

  8. Time-effectiveness

    To compare time-effectiveness between standard and CPAP-assisted RT

    • Set-up time
    • Matching time
    • Radiation time

    Measured: From enrollment to the end of treatment at +/-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start11 Feb 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
prospective clinical trial
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07373782
Sponsor's protocol ID
S68702
Status last verified
Apr 2025
First submitted
10 Dec 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van der Vorst A, Verhoeven J, Baten A, Janssen H, Van Bavel L, Delombaerde L, Reynders T, Cooreman M, Laenen A, Lambrecht M, Van AL, Weltens C. Continuous positive airway pressure in breast cancer radiotherapy: Protocol of a prospective clinical trial. Clin Transl Radiat Oncol. 2026 Jun 3;59:101209. doi: 10.1016/j.ctro.2026.101209. eCollection 2026 Jul.

    PubMed 42305413

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Continuous Positive Airway Pressure (CPAP) in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aline Van der Vorst, MD (+3216340115, aline.vandervorst@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean heart dose (time frame: From enrollment to the end of treatment at +/-8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07373782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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