CPAP or BiPAP for Motion Mitigation During Radiotherapy

NCT04986293 | Recruiting

• 1 other identifier: NL71871.042.19/RT2019-17
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiotherapy Side Effect; NSCLC; Esophageal Cancer; Malignant Lymphoma

Keywords

BiPAP; CPAP; Mechanical ventilation

Outcome Measures

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

  2-3 hours of measurement (only once)

Secondary Outcomes (2)

• Feasibility of mechanical ventilation

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

• Feasibility of mechanical ventilation

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

Interventions

CPAP DEVICE

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

Also known as: BiPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Facial deformations so that facial mask is impossible to fit
• Planned for radiotherapy with fraction dose ≥3 Gy.
• Severe heart failure (LVEF\<30%)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Esophageal Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Wounds and Injuries; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robin Wijsman

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Wijsman

CONTACT

+31503612711; info@rt.umcg.nl

J. Elshof

CONTACT

+31503611036; j.elshof@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 2, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)