CPAP or BiPAP for Motion Mitigation During Radiotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will follow a 2-step approach. First (Phase 1, n=10), the feasibility of short-term use of CPAP and BiPAP and its effects on (regional) lung volumes, tidal volumes and breathing frequency will be investigated in patients with intra-thoracic tumors who are planned for radiotherapy. This is necessary to select the best setting of CPAP or BiPAP with which minimal tumor motion is expected (and that is feasible for the patient). In the second phase (n=21), the particular setting found in fase 1 is investigated: weekly repeated radiotherapy planning (4D) CT scans with and without CPAP/BiPAP will be aquired to evaluate the influence on tumor motion and dose to the target and organs at risk. Radiotherapy will be deliverd according to local protocol without the use of CPAP/BiPAP.

Official Title
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Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy

Conditions
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Radiotherapy Side Effect, NSCLC, Esophageal Cancer, Malignant Lymphoma

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CPAP|Different settings of CPAP and BiPAP will be tested using a home mechanical ventilator|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2-3 hours of measurement (only once) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of mechanical ventilation | Feasibility is expressed as a score (using a Visual Analoge Scale) | once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy) | 
| Feasibility of mechanical ventilation | Feasibility is expressed as the duration (minutes) the participant can undergo mechanical ventilation | once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BiPAP, CPAP, Mechanical ventilation