Using CPAP or BiPAP to reduce tumor movement during radiotherapy
Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy
This study is testing if using CPAP or BiPAP can help control breathing and reduce tumor movement during radiation treatment for patients with lung tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT04986293 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using CPAP and BiPAP to control breathing patterns in patients with intra-thoracic tumors undergoing radiotherapy. In the first phase, the effects of these ventilators on lung volumes and breathing frequency will be assessed in a small group of patients. The second phase will involve evaluating the optimal settings determined in phase one during repeated radiotherapy planning CT scans to measure their impact on tumor motion and radiation dose to surrounding organs. The goal is to enhance treatment precision for patients with advanced stage cancers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage III/IV non-small cell lung cancer, esophageal cancer, or malignant lymphoma who are receiving curative radiotherapy.
Not a fit: Patients with facial deformities that prevent the use of a facial mask or those with severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy of radiotherapy, potentially leading to better treatment outcomes for patients with advanced cancers.
How similar studies have performed: While the use of CPAP and BiPAP in this context is innovative, similar studies have shown promise in reducing tumor motion during radiotherapy.
Eligibility criteria
Show full inclusion / exclusion 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%)
Where this trial is running
Groningen, Provincie Groningen
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Robin Wijsman — University Medical Center Groningen
- Study coordinator: Robin Wijsman
- Email: info@rt.umcg.nl
- Phone: +31503612711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.