Radiotherapy Side EffectSISTERNCT04986293
CPAP or BiPAP for Motion Mitigation During Radiotherapy
A study testing CPAP in people with Radiotherapy Side Effect and NSCLC, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy Side Effect, NSCLC, Esophageal Cancer
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB
Robin Wijsman, +31503612711, info@rt.umcg.nl
About this study
Official title: Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With 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.
Read the detailed 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.
- Conditions
- Radiotherapy Side Effect, NSCLC, Esophageal Cancer, Malignant Lymphoma
- Being tested
- CPAP
- Keywords
- BiPAP, CPAP, Mechanical ventilation
- Medical subject headings
- Radiation Injuries, Esophageal Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called BiPAP
Different settings of CPAP and BiPAP will be tested using a home mechanical ventilator
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-3 hours of measurement (only once)
Secondary outcomes (2)
Feasibility of mechanical ventilation
Feasibility is expressed as a score (using a Visual Analoge Scale)
Measured: 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
Measured: once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Jun 2021
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Wijsman, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986293
- Sponsor's protocol ID
- NL71871.042.19/RT2019-17
- Acronym
- SISTER
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy
- ClinicalTrials.gov ID
- NCT04986293
- Acronym / sponsor ID
- SISTER / NL71871.042.19/RT2019-17
- Conditions
- Radiotherapy Side Effect, NSCLC, Esophageal Cancer, Malignant Lymphoma
- Keywords
- BiPAP, CPAP, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: BiPAPDifferent settings of CPAP and BiPAP will be tested using a home mechanical ventilator | Device | – |
Primary outcome
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
2 secondary outcomes
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 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin Wijsman principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Radiotherapy Side Effect and NSCLC, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin Wijsman (+31503612711, info@rt.umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung volume changes induced by the use of mechanical ventilation (time frame: 2-3 hours of measurement (only once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.