CancerCPAP-RTNCT05396950
CPAP for Motion Management in Breast Radiotherapy; and Lung & Liver SABR
A study testing CPAP in people with Cancer, run by Waikato Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cannot tolerate CPAP e.g due to severe claustrophobia
- Re-irradiation
Trial locations and contacts
No sites are listed yet.
About this study
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
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:
- Displacing the heart away from the radiotherapy field
- Reducing the volume of functional lung irradiated
- 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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP in conjunction with radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| CPAP Planned | Experimental | Radiotherapy planning with CPAP in addition to standard plans Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-12 months
Secondary outcomes (2)
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
Measured: 6-12 months
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
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study startOct 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within subject comparison
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waikato Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenanao D Rantshilane, MBBS, Principal investigator, Waikato Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396950
- Sponsor's protocol ID
- UTN: U1111-1278-1680
- Acronym
- CPAP-RT
- Status last verified
- May 2024
- First submitted
- 10 Apr 2022
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05396950
- Acronym / sponsor ID
- CPAP-RT / UTN: U1111-1278-1680
- Conditions
- Cancer
- Keywords
- SABR, CPAP, Breast, Lung, Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Waikato HospitalUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Displacing the heart away from the radiotherapy field
- Reducing the volume of functional lung irradiated
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subject comparison
| Arm | Type | Receives |
|---|---|---|
| CPAP Planned | Experimental | Device: CPAPRadiotherapy planning with CPAP in addition to standard plans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cannot tolerate CPAP e.g due to severe claustrophobia
- Re-irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPCPAP in conjunction with radiotherapy | Device | CPAP Planned |
Primary outcome
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
2 secondary outcomes
Organ at Risk Dose Constraints
Time frame: 6-12 months
Compliance and Tolerability
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenanao D Rantshilane, MBBS principal investigator
Waikato Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Cancer, run by Waikato Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Jameson, FRACP (+64 7 839 8899, Michael.jameson@waikatodhb.health.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiotherapy Plan Selection (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.