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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56026
Enrollment
90
Registered
2021-07-26
Start date
2022-03-10
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Gezonde proefpersonen zonder aandoeningen. Patiënten die met radiotherapie voor kanker in het thoracale gebied (borst, long, mediastinum) en in het abdomen (levertumoren/metastasen, alvleesklierkanker). Organ motion

Interventions

• Healthy volunteers and cancer patients are trained in two sessions to undergo non-invasive mechanical (and high-frequenciy) ventilation via a face/nose mask. (Note: Subjects are not under anaesthe
they can stop the intervention at any time). • Patients will be trained in one session to undergo non-invasive ventilation (with varying frequencies) via a mouth/nose mask. (Note: Patients are not u
they can stop the intervention at any time). • In healthy volunteers, ultrasound imaging will acquired in the second session. Then, in two subsequent sessions, MR images are acquired during the non

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • age >18 years • adequate communication and understanding skills of Dutch language • patients 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: • 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 • latex allergy • any 3T MRI contra-indications as stated by the AMC MR safety committee

Design outcomes

Primary

MeasureTime frame
The main outcome is the feasibility to achieve the diverse breathing control strategies in healthy volunteers and cancer patients to quantify reduced organ motion, and in patients to reduce dose to notmal tissues and organs at risk as compared to strategies currently used in clinical practice (i.e. multiple deep inspiration short breath-holds, or free breathing).

Secondary

MeasureTime frame
The secundairy parameters are: • the practical advantages and limitations of the breathing control strategies for routinely radiotherapy delivery in cancer patients • cost effectiveness in terms of time investment • subjects* comfort with the different breathing control strategies assessed by the included subjects Other study parameters: • systolic blood pressure • oxygen saturation • heart rate • end tidal partial pressure of carbon dioxide

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)