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

Q: Who can participate in NCT07373782?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07373782?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer (NCT07373782) is a Phase 2 / Phase 3 interventional studying Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Universitaire Ziekenhuizen KU Leuven. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Breast Cancer Early Stage Breast Cancer (Stage 1-3) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 53 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Breast Cancer Early Stage Breast Cancer (Stage 1-3) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntary written willing to sign a consent form 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 willing to sign a consent form 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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Continuous Positive Airway Pressure (CPAP)

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

UZ Leuven

Leuven, Belgium

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07373782), the sponsor (Universitaire Ziekenhuizen KU Leuven), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07373782 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07373782?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07373782?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07373782. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07373782. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.