NCT04986293 CPAP or BiPAP for Motion Mitigation During Radiotherapy
| NCT ID | NCT04986293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Radiotherapy Side Effect |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 31 participants in total. It began in 2021-06-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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%)
Contact & Investigator
Robin Wijsman
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT04986293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiotherapy Side Effect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04986293 currently recruiting?
Yes, NCT04986293 is actively recruiting participants. Contact the research team at info@rt.umcg.nl for enrollment information.
Where is the NCT04986293 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT04986293 clinical trial?
NCT04986293 is sponsored by University Medical Center Groningen. The principal investigator is Robin Wijsman at University Medical Center Groningen. The trial plans to enroll 31 participants.