NCT04986293Recruiting
CPAP or BiPAP for Motion Mitigation During Radiotherapy
Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
When using highly conformal radiotherapy techniques, such as proton therapy, a controlled breathing pattern and a minimal breathing amplitude could greatly benefit the treatment of mobile tumors. This reduction in tumor motion may be achieved with the use of a ventilator that is able to regulate and modulate the breathing pattern. CPAP provides a constant level of positive airway pressure. Compared to spontaneous breathing, the use of CPAP increased lung volume and can result in a significant decrease in tumor movement and a significant decrease in both mean lung and mean heart radiation dose. These results were found in patients treated for limited stage disease, it is not clear if this approach is feasible for patients with more advanced stage of disease that undergo radiotherapy with curative intent. With Bilevel Positive Airway Pressure (BiPAP), tidal volume excursions are determined by the pressure difference between the set inspiratory positive airway pressure (IPAP) and the set expiratory positive airway pressure (EPAP). This mode of ventilation increases lung volume comparable to CPAP, but also to control tidal volumes and breathing frequency. However, BiPAP has never been studied in the setting of motion mitigation during radiotherapy and BiPAP might be more difficult to adjust to for patients compared to CPAP. Therefore, the current study is proposed to evaluate whether or not CPAP or BiPAP is of benefit in patients that undergo radiotherapy for larger intra-thoracic tumor volumes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 1 Jul 2021
- Start date
- Jun 2021
- Primary completion date
- Jul 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04986293
What you commit to
- Study type: Interventional
- Planned participants: 31
- From Jun 2021 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned for radiotherapy with fraction dose ≥3 Gy.
Lab values
- Severe heart failure (LVEF\<30%)
Other
- Facial deformations so that facial mask is impossible to fit
- Noncompliance with any of the inclusion criteria.
Who the study is looking for
- Age ≥18 years
- Stage III/IV (N)SCLC, esophageal cancer or malignant lymphoma that will be treated with curative intent
- WHO 0-2.
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.