NCT05396950

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. 1.Displacing the heart away from the radiotherapy field
  2. 2.Reducing the volume of functional lung irradiated
  3. 3.Reducing the radiotherapy target motion

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2025Jul 2026

First Submitted

Initial submission to the registry

April 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
3.3 years until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 24, 2025

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

April 10, 2022

Last Update Submit

April 21, 2025

Conditions

Cancer

Keywords

SABRCPAPBreastLungLiver

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Organ at Risk Dose Constraints

    6-12 months

  • Compliance and Tolerability

    6-12 months

Study Arms (1)

CPAP Planned

EXPERIMENTAL

Radiotherapy planning with CPAP in addition to standard plans

Device: CPAP

Interventions

CPAPDEVICE

CPAP in conjunction with radiotherapy

CPAP Planned

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cannot tolerate CPAP e.g due to severe claustrophobia
  • Re-irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Kenanao D Rantshilane, MBBS

    Waikato Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Jameson, FRACP

CONTACT

+64 7 839 8899Michael.jameson@waikatodhb.health.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within subject comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2022

First Posted

May 31, 2022

Study Start

October 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 24, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share