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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05396950
Acronym
CPAP-RT
Enrollment
70
Registered
2022-05-31
Start date
2025-10-31
Completion date
2026-07-31
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

SABR, CPAP, Breast, Lung, Liver

Brief summary

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.

Detailed description

PRIMARY OBJECTIVE: To determine the proportion of patients where the use of CPAP results in a superior radiation plan compared to standard planning procedures in each patient cohort SECONDARY OBJECTIVES To determine: * Impact of CPAP on treatment delivery time; * Impact of CPAP on total lung volume; * CPAP compliance; * Patient experience; Breast-specific: • Comparison of organ at risk (OAR) dose constraints between CPAP and deep DIBH) SABR-specific: * Internal target volume (ITV) reduction; * OAR dose constraints between CPAP and standard planning procedures. Breast cancer patients will undergo normal free breathing and DIBH radiotherapy planning scans. An additional scan with CPAP will be done for the purpose of the study. Radiotherapy plans will be produced on both the DIBH and CPAP planning scans. The planning scan with the best dosimetry will be chosen for treatment. If CPAP has a better radiation plan, then the patient will have CPAP administered during their daily RT. The DIBH plans for each patient, will serve as controls SABR patients will undergo the standard 4-D or breath hold CT and then CPAP CT for the purpose of the study. Respiratory movements will be monitored by Varian RPM system. Radiotherapy plans will be produced from the standard CT and the CPAP CT for comparison. Patients will be treated on the best plan The trial aim to recruit 70 patients with invasive carcinoma of the breast undergoing adjuvant radiotherapy that includes breast/chest-wall plus regional lymph nodes, and a convenient sample size of those undergoing SABR to lung or liver

Interventions

DEVICECPAP

CPAP in conjunction with radiotherapy

Sponsors

Waikato Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Within subject comparison

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radiotherapy Plan Selection6-12 monthsTo 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

MeasureTime frameDescription
Organ at Risk Dose Constraints6-12 monthsComparison of organ at risk dose constraints between CPAP assisted and standard RT plans Breast-specific: * A comparison of OAR dose constraints in CPAP vs DIBH including: * Mean Heart Dose, V20Gy heart * Ipsilateral lung V16Gy and V5Gy SABR-Specific * A comparison of OAR dose constraints in CPAP vs DIBH including: * Lung V20Gy, Mean Lung Dose * Heart V40Gy, Mean heart Dose * Liver V15Gy, Mean liver Dose, Liver -GTV
Compliance and Tolerability6-12 monthsAssessment of compliance with CPAP as well as documentation of patient experiences • Patient experience as documented on a questionnaire after planning CT and on the last week of treatment

Contacts

Primary ContactMichael Jameson, FRACP
Michael.jameson@waikatodhb.health.nz+64 7 839 8899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026