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SISTER: CPAP or BiPAP for Motion Mitigation During Radiotherapy

Sponsor
University Medical Center Groningen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04986293
Collaborator
(none)
31
Enrollment
1
Location
30
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

When using highly conformal radiotherapy techniques, such as proton therapy, a controlled breathing pattern and a minimal breathing amplitude could greatly benefit the treatment of mobile tumors. This reduction in tumor motion may be achieved with the use of a ventilator that is able to regulate and modulate the breathing pattern. CPAP provides a constant level of positive airway pressure. Compared to spontaneous breathing, the use of CPAP increased lung volume and can result in a significant decrease in tumor movement and a significant decrease in both mean lung and mean heart radiation dose. These results were found in patients treated for limited stage disease, it is not clear if this approach is feasible for patients with more advanced stage of disease that undergo radiotherapy with curative intent.

With Bilevel Positive Airway Pressure (BiPAP), tidal volume excursions are determined by the pressure difference between the set inspiratory positive airway pressure (IPAP) and the set expiratory positive airway pressure (EPAP). This mode of ventilation increases lung volume comparable to CPAP, but also to control tidal volumes and breathing frequency. However, BiPAP has never been studied in the setting of motion mitigation during radiotherapy and BiPAP might be more difficult to adjust to for patients compared to CPAP. Therefore, the current study is proposed to evaluate whether or not CPAP or BiPAP is of benefit in patients that undergo radiotherapy for larger intra-thoracic tumor volumes.

Condition or Disease Intervention/Treatment Phase
  • Device: CPAP
 N/A

Detailed Description

The study will follow a 2-step approach.

First (Phase 1, n=10), the feasibility of short-term use of CPAP and BiPAP and its effects on (regional) lung volumes, tidal volumes and breathing frequency will be investigated in patients with intra-thoracic tumors who are planned for radiotherapy. This is necessary to select the best setting of CPAP or BiPAP with which minimal tumor motion is expected (and that is feasible for the patient).

In the second phase (n=21), the particular setting found in fase 1 is investigated: weekly repeated radiotherapy planning (4D) CT scans with and without CPAP/BiPAP will be aquired to evaluate the influence on tumor motion and dose to the target and organs at risk. Radiotherapy will be deliverd according to local protocol without the use of CPAP/BiPAP.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Continuous and Bi-level Positive Airway Pressure for Motion Mitigation of Intra-thoracic Tumors Treated With Radiotherapy
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Lung volume changes induced by the use of mechanical ventilation [2-3 hours of measurement (only once)]

    The primary objective is to evaluate the lung volume changes (in cm3) induced by the use of mechanical ventilation

Secondary Outcome Measures

  1. Feasibility of mechanical ventilation [once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy)]

    Feasibility is expressed as a score (using a Visual Analoge Scale)

  2. Feasibility of mechanical ventilation [once every week up to a maximum of 5 consecutive weeks (depending on the duration of the course of radiotherapy)]

    Feasibility is expressed as the duration (minutes) the participant can undergo mechanical ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥18 years

  • Stage III/IV (N)SCLC, esophageal cancer or malignant lymphoma that will be treated with curative intent

  • WHO 0-2.

  • Written informed consent

Exclusion Criteria:

  • Facial deformations so that facial mask is impossible to fit

  • Noncompliance with any of the inclusion criteria.

  • Planned for radiotherapy with fraction dose ≥3 Gy.

  • Severe heart failure (LVEF<30%)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Groningen Groningen Netherlands 9700 RB

Sponsors and Collaborators

  • University Medical Center Groningen

Investigators

  • Principal Investigator: Robin Wijsman, UMCG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
R. Wijsman, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT04986293
Other Study ID Numbers:
  • NL71871.042.19/RT2019-17
First Posted:
Aug 2, 2021
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by R. Wijsman, Principal Investigator, University Medical Center Groningen
BiPAP
CPAP
Mechanical ventilation
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Aug 2, 2021