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NCT Number: NCT05396950

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

CPAP in conjunction with radiotherapy

Primary outcomes

  1. Radiotherapy Plan Selection

    Time frame: 6-12 months

    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

  1. Organ at Risk Dose Constraints

    Time frame: 6-12 months

    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

  2. Compliance and Tolerability

    Time frame: 6-12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Jameson, FRACP

CONTACT

[email protected]

+64 7 839 8899

Sponsors and collaborators

Lead sponsor

Waikato Hospital

Other

Registry information

Official study 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

Acronym: CPAP-RT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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