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

Recruiting

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

Registration Number: NL-OMON56026

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

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

• asthma controlled by medication
• moderately to severely impaired lung function (FEV1 <30% of predicted)
• resting PetCO2 >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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