Clinical trial · Interventional
CPAP for Motion Management in Breast Radiotherapy; and Lung & Liver SABR
A Non Randomised Comparative Phase II Trial to Determine the Benefit of Continuous Positive Airway Pressure-assisted Radiotherapy vs Deep Inspiration Breath Hold in Breast Cancer and in Lung & Liver Stereotactic Ablative Body Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase II trial to determine the proportion of patients where the use of continuous positive airway pressure (CPAP) results in a superior radiation plan compared to standard planning procedures. The rationale for using CPAP with radiotherapy is based on its ability to increase the tidal volume, flatten the diaphragm thus reducing respiratory excursions.The resultant lung hyperinflation and reduced respiratory excursions can be harnessed for radiotherapy purposes by: 1. Displacing the heart away from the radiotherapy field 2. Reducing the volume of functional lung irradiated 3. Reducing the radiotherapy target motion CPAP has been shown to be superior to free breathing radiotherapy (RT), however it remains unclear how much benefit it confers vs other motion management adjuncts such as deep inspiration breath hold (DIBH) or 4-DCT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPAP | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CPAP Planned
- description
- Radiotherapy planning with CPAP in addition to standard plans
- interventionNames
- Device: CPAP
Primary outcomes (1)
- measure
- Radiotherapy Plan Selection
- timeFrame
- 6-12 months
- description
- To determine the proportion of patients where the use of continuous positive airway pressure (CPAP) results in a superior radiation plan compared to standard planning procedures in each patient cohort
Secondary outcomes (2)
- measure
- Organ at Risk Dose Constraints
- timeFrame
- 6-12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with pathologically-confirmed invasive breast cancer and planned for adjuvant radiotherapy to the breast or chest-wall with regional lymph node coverage * Any patient deemed suitable for lung or liver SABR as per departmental guidelines * Must have signed written informed consent Exclusion Criteria: * Cannot tolerate CPAP e.g due to severe claustrophobia * Re-irradiation
References
Publications (0)
Data not yet available