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Investigating breathing training for lung cancer radiotherapy

Multi-institutional, randomised clinical investigation of the breathing training system: audiovisual biofeedback to improve breathing regularity and reduce medical imaging errors for lung cancer patients undergoing radiotherapy.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001177741
Acronym
Audio-Visual Investigation Advancing Thoracic Radiotherapy (AVIATOR)
Enrollment
22
Registered
2013-10-28
Start date
2016-04-11
Completion date
Unknown
Last updated
2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Purpose: This study is investigating whether the breathing training system can improve breathing regularity and reduce medical imaging errors in lung cancer patients undergoing radiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with lung cancer, for which you are scheduled to undergo radiation treatment. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will use the audiovisual (AV) biofeedback breathing training system during radiotherapy treatment if deemed helpful. AV biofeedback is an interactive, personalised and non-invasive breathing training system designed to assist the patient to breathe regularly. AV biofeedback is comprised of the real-time position management (RPM) system and a visual display (e.g. monitor, tablet computer), none of which are of any risk to the patient. The system is designed to be easily implemented into any treatment or imaging facilities. The patient views the tablet screen which displays their breathing pattern to them based on the real-time respiratory motion captured by the RPM system. Participants in the other group will receive treatment as usual, i.e. radiotherapy without breathing training. Participants will be monitored during treatment in order to determine whether AV biofeedback makes breathing more regular for imaging and treatment procedures during radiotherapy. Hypothesis: We hypothsise that AV biofeedback will significantly improve breathing regularity and reduce medical imaging errors for lung cancer patients undergoing imaging and treatment procedures during radiotherapy. Successful completion of this trial and positive testing of the primary hypothesis will give clinicians a simple tool to improve breathing regularity and reduce imaging and treatment errors for cancer radiotherapy patients.

Interventions

There is a clear link between irregular breathing and errors in medical imaging and radiation treatment. To address the problem of irregular breathing, a respiratory guidance system has been developed by our research group: audiovisual (AV) biofeedback. AV biofeedback is an interactive, personalised and non-invasive breathing training system designed to assist the patient to breathe regularly. AV biofeedback is comprised of the real-time position management (RPM) system and a visual display (e.g

There is a clear link between irregular breathing and errors in medical imaging and radiation treatment. To address the problem of irregular breathing, a respiratory guidance system has been developed by our research group: audiovisual (AV) biofeedback. AV biofeedback is an interactive, personalised and non-invasive breathing training system designed to assist the patient to breathe regularly. AV biofeedback is comprised of the real-time position management (RPM) system and a visual display (e.g. monitor, tablet computer), none of which are of any risk to the patient. The system is designed to be easily implemented into any treatment or imaging facilities. The patient views the tablet screen which displays their breathing pattern to them based on the real-time respiratory motion captured by the RPM system. AV biofeedback will be used during every radiotherapy and imaging session. As for the period and frequency of such sessions, it will vary from site to site and between patients depending on the type of treatment prescribed to them (e.g. 3D-conformal, stereotactic body radiation therapy, or intensity-modulated radiation therapy). Patients in the intervention arm will undergo a screening procedure that will determine what breathing condition is best used for their treatment: either free breathing or AV biofeedback. This will take the form of a breathing session in which we will record the patient's free breathing and analyse the reproducibility of its amplitude and period. This will then be repeated using AV biofeedback, and which ever breathing condition resulted in the most reproducible breathing signal will be the one to continue to be used throughout the patient's imaging and treatment.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) Lung cancer patients (no restrictions to type of radiotherapy being received) 2) >18 years old 3) No gender or ethnic restrictions 4) An ECOG score in the range of 0 to 2 5) Able to give written informed consent and willingness to participate and comply with the study

Exclusion criteria

1) Non-lung cancer patients 2) Pregnant / lactating woman 3) An ECOG score greater than 2

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026