CPAP or BiPAP for Motion Mitigation During Radiotherapy

Esophageal Cancer Clinical Trial

— SISTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986293
• Other study ID #: NL71871.042.19/RT2019-17
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: University Medical Center Groningen
• Contact: Robin Wijsman
• Phone: +31503612711
• Email: info[@]rt.umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Esophageal Cancer
• Lymphoma
• Malignant Lymphoma
• NSCLC
• Radiotherapy Side Effect

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)