Continuous and Bi-level positive airway pressure for motion mitigation of intra-thoracic tumors treated with radiotherapy

Continuous and Bi-level positive airway pressure for motion mitigation of intra-thoracic tumors treated with radiotherapy - Mechanical ventilation for motion mitigation during radiotherapy.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49188

Enrollment

Registered

2020-07-21

Start date

2021-06-29

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

esophageal cancer lung cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Intra-thoracic malignancy (locoregionally advanced stage lung cancer, esophageal cancer or malignant lymphoma) that wil be treated with curative intent with radiotherapy. Informed consent needs te bo obtained. Age: 18 years or older.

Exclusion criteria

Exclusion criteria: • Facial deformations so that facial mask are impossible to fit • Noncompliance with any of the inclusion criteria. • Planned for radiotherapy with fraction dose >=3 Gy. • Severe heart failure (LVEF

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the effect of CPAP or BiPAP on tumor motion (tumor amplitude expressed in millimeters) during the course of radiotherapy.	—

Secondary

Measure	Time frame
Phase 1: Feasibility of the use of CPAP and BiPAP in terms of the time a patient can use CPAP or BiPAP. We consider it feasible in case patients can wear the mask more than 10 minutes. Phase 2: Change in lung volumes (based on CT images); tidal volumes and breathing frequency with the use of CPAP or BiPAP in healthy controls and patients with intra-thoracic tumors. Feasibility of CPAP or BiPAP use for patients with intra-thoracic tumors. To evaluate this, the duration of wearing the mask will be monitored. We consider it feasible in case patients can wear the mask more than 10 minutes. Reproducibility of controlling lung volumes during the course of radiotherapy by evaluation of the base-line shift. The influence of the anticipated reduction in target volume and the consequences for the dose distributions (to the target and to the organs at risk) for both photon and proton based radiotherapy plans (with and without mechanical ventilation).	—

Measure

Time frame

Phase 1: Feasibility of the use of CPAP and BiPAP in terms of the time a patient can use CPAP or BiPAP. We consider it feasible in case patients can wear the mask more than 10 minutes. Phase 2: Change in lung volumes (based on CT images); tidal volumes and breathing frequency with the use of CPAP or BiPAP in healthy controls and patients with intra-thoracic tumors. Feasibility of CPAP or BiPAP use for patients with intra-thoracic tumors. To evaluate this, the duration of wearing the mask will be monitored. We consider it feasible in case patients can wear the mask more than 10 minutes. Reproducibility of controlling lung volumes during the course of radiotherapy by evaluation of the base-line shift. The influence of the anticipated reduction in target volume and the consequences for the dose distributions (to the target and to the organs at risk) for both photon and proton based radiotherapy plans (with and without mechanical ventilation).

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Countries

Netherlands

Outcome results