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

NCT07373782 | Recruiting Phase 2

• 1 other identifier: S68702
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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

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

Keywords

breast cancer; radiotherapy; cpap; continuous positive airway pressure; dosimetry; toxicity

Outcome Measures

Primary Outcomes (1)

• Mean heart dose

  Potential change of mean radiation dose to the heart

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

Secondary Outcomes (8)

• Doses to cardiac substructures

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

• Mean lung dose

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

• Mean contralateral breast dose

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

• Liver dose

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

• Patient comfort

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

Study Arms (2)

CPAP-addition

EXPERIMENTAL

CPAP is added to standard of care

Device: Continuous Positive Airway Pressure (CPAP)

Standard of care

NO INTERVENTION

Right sided or 70 years or older: Free Breathing Left sided and younger than 70 years old: Deep Inspiration Breath Hold

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

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

CPAP-addition

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VitalAire: collaborator
• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Microcephaly, Primary Autosomal Recessive, 6

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Aline Van der Vorst, MD

CONTACT

+3216340115; aline.vandervorst@uzleuven.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective clinical trial

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 28, 2026
• Study Start: February 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)