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Reduction of organ motion during radiotherapy by non-invasive mechanical ventilation supported breathing control.

Breathing control in radiotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24117
Enrollment
90
Registered
2021-03-29
Start date
2021-10-17
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cancer (breast cancer, mediastinal tumours, lung cancer, liver tumours and pancreatic cancer). (Note: we will also include healthy volunteers).

Interventions

Subjects will be trained in approximately two sessions to feel safe and comfortable while being mechanically ventilated via a face mask and viral filter. Step by step they learn to to achieve safely c

Sponsors

Amsterdam UMC - Radiotherapy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, subjects must meet all of the following criteria: • age >18 years • adequate communication and understanding skills of Dutch language • referred to or undergoing radiotherapy with DIBH at the department of radiation oncology of the Amsterdam UMC • condition: KPS >70 or WHO PS max 1 (see 4.3 Exclusion criteria) • signed informed consent (IC)

Exclusion criteria

Exclusion criteria: Any potential subject with (a history of) any of the following conditions will be excluded from participation in this study: • asthma controlled by medication • moderately to severely impaired lung function (FEV1 50 mmHg • manifest cardiac failure • epilepsy • hypertension uncontrolled by medication • brain disease, and/or anomalies of the brain’s vasculature or previous TIA/CVA • morbid obesity, i.e. BMI >40 kg/m2 • pneumothorax • renal failure • claustrophobia • current pregnancy • any 3T MRI contra-indications as stated by the AMC MR safety committee Furthermore, patients will be excluded if they have: • any tumour that is not clinically definable on planning CT due to e.g. surrounding consolidation or atelectasis • a tumour located within 2cm radius of main airways and proximal bronchial tree

Design outcomes

Primary

MeasureTime frame
The main endpoint is the feasibility to achieve regularized breathing, compensated prolonged breath-holding and high frequency ventilation in healthy volunteers and cancer patients to quantify reduced dose to organs at risk as compared to DIBH and FB.

Secondary

MeasureTime frame
The secondary endpoints are reached if the practical advantages and limitations of the novel breathing control strategies for routinely radiotherapy delivery in cancer patients have been identified, i.e.: • subjects’ comfort with the different breathing control strategies has been assessed using a short questionnaire; • cost effectiveness in terms of time investment has been analysed.

Contacts

Public ContactIrma W.E.M. van Dijk

Amsterdam UMC, location Academic Medical Center

i.w.vandijk@amsterdamumc.nl+31 (0) 5666823

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)