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Recruiting Not applicable

CPAP or BiPAP for Motion Mitigation During Radiotherapy

NCT04986293 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2021-06-01
Last updated
2026-05-04

Condition(s) studied

Radiotherapy Side EffectNSCLCEsophageal CancerMalignant Lymphoma

Investigational drug(s) / intervention(s)

CPAP

CPAP: Different settings of CPAP and BiPAP will be tested using a home mechanical ventilator

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Facial deformations so that facial mask is impossible to fit * Noncompliance with any of the inclusion criteria. * Planned for radiotherapy with fraction dose ≥3 Gy. * Severe heart failure (LVEF\<30%)

Primary outcome measure(s)

  • Lung volume changes induced by the use of mechanical ventilation — 2-3 hours of measurement (only once)
    The primary objective is to evaluate the lung volume changes (in cm3) induced by the use of mechanical ventilation

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Groningen Groningen Provincie Groningen Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04986293 on ClinicalTrials.gov ↗ ← All trials in the Netherlands