CPAP for Motion Management in Breast Radiotherapy; and Lung & Liver SABR

Cancer Clinical Trial

— CPAP-RT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05396950
• Other study ID #: UTN: U1111-1278-1680
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Waikato Hospital
• Contact: Michael Jameson, FRACP
• Phone: +64 7 839 8899
• Email: Michael.jameson[@]waikatodhb.health.nz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• CPAP
CPAP in conjunction with radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Waikato Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiotherapy Plan Selection	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	6-12 months
Secondary	Organ at Risk Dose Constraints	Comparison 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	6-12 months
Secondary	Compliance and Tolerability	Assessment 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	6-12 months