Health TrialsbyHealthPanel

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

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWaikato Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Cannot tolerate CPAP e.g due to severe claustrophobia

Re-irradiation

Trial design

Design model

Single group

Treatments tested in this trial

  • CPAP

    Device

    CPAP in conjunction with radiotherapy

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: CPAP PlannedExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6-12 months

Secondary outcomes

1

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

Time frame
6-12 months
2

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

Time frame
6-12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Waikato Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: