CPAP or BiPAP for Motion Mitigation During Radiotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%)

Trial design

Design model

Single group

Treatments tested in this trial

  • CPAP

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Lung volume changes induced by the use of mechanical ventilation

The primary objective is to evaluate the lung volume changes (in cm3) induced by the use of mechanical ventilation

Time frame
2-3 hours of measurement (only once)

Secondary outcomes

1

Feasibility of mechanical ventilation

Feasibility is expressed as a score (using a Visual Analoge Scale)

Time frame
once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy)
2

Feasibility of mechanical ventilation

Feasibility is expressed as the duration (minutes) the participant can undergo mechanical ventilation

Time frame
once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy)

Other outcomes

Sponsors and contacts

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