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| Name | Class |
|---|---|
| VitalAire | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP-addition | Experimental | CPAP is added to standard of care |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Device | Positive airway pressure (15cmH2O) delivered by a CPAP-device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aline Van der Vorst, MD | Contact | +3216340115 | aline.vandervorst@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42305413 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2025 | Jan 22, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| C564247 | Microcephaly, Primary Autosomal Recessive, 6 |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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prospective clinical trial
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| 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
| From enrollment to the end of treatment at +/-8 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012138 |
| Respiratory Therapy |