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NCT Number: NCT04986293

CPAP or BiPAP for Motion Mitigation During Radiotherapy

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.

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Key information

Conditions

Radiotherapy Side Effect Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Malignant Lymphoma NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location status: Recruiting

Location contact

Robin Wijsman

CONTACT

[email protected]

+31503612711

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

CPAP

Device

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

Other names: BiPAP

Primary outcomes

  1. Lung volume changes induced by the use of mechanical ventilation

    Time frame: 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

Secondary outcomes

  1. Feasibility of mechanical ventilation

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

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

  2. Feasibility of mechanical ventilation

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

J. Elshof

CONTACT

[email protected]

+31503611036

Robin Wijsman

CONTACT

[email protected]

+31503612711

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: SISTER

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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