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Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment

Primary Purpose

Lung Cancer, Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
High Frequency Percussive Ventilation
Free breathing
Active Breathing Control
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • breast cancer eligible for tomotherapy or linear accelerator with ABC system
  • lung cancer eligible for curative tomotherapy and with a significant breathing movements amplitude
  • lung cancer eligible for ablative stereotaxis
  • WHO 0 or 1

Exclusion Criteria:

  • patients requiring oxygen or not able to lie on the back (dyspnea)
  • pulmonary functions altered
  • cardiac insufficiency
  • patient not able to breathe with the High Frequency Ventilation System
  • risk of pneumothorax when experiencing High Frequency Ventilation

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tomotherapy (HFPV vs free breathing)

linear accelerator (HFPV vs ABC)

Arm Description

Tomotherapy: locally advanced lung cancer (Stage III) or left breast cancer. High Frequency Percussive Ventilation will be coupled to tomotherapy treatment. The alternative procedure is free breathing.

Linear accelerator: breast cancer or pulmonary cancers (Stage I/II) requiring a stereotaxic radiotherapy. High Frequency Percussive Ventilation will be coupled to linear accelerator. The alternative procedure is Active Breathing Control (ABC).

Outcomes

Primary Outcome Measures

HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast)
Radiotherapy treatment fractions (locally advanced lung: 33 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start. Dose distribution will be determined for both situations and patients will be treated with the most favourable one.
HFPV vs ABC: decrease the duration of radiotherapy fractions (lung: 1/2 and breast 1/3)
Lung (5 fractions) or breast (25 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start. The time of fractions administration will be compared to theoretical times of treatment when patient is free breathing (lung 45 min for 12Gy/ breast 10 min for 2Gy).

Secondary Outcome Measures

Full Information

First Posted
August 30, 2016
Last Updated
March 9, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT02936947
Brief Title
Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment
Official Title
Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
due to Covid19 restrictions
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment in patients with tumors that are moving with respiration like breast or lung cancers. The use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory motions while administering radiotherapy (RT) to tumors which allows a reduction of the amount of irradiated normal tissues and which potentially decrease radiation-induced collateral damages.
Detailed Description
Primary objective : Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations : Tomotherapy for lung and left breast tumors. The investigators assume that the volume of irradiated healthy tissue will be much less when using HFPV as compared to free breathing during tomotherapy sessions . In comparison with Active Breathing Control (ABC system). The investigators assume that the HFPV will lead to breathing motions cessation the same way as the ABC system, but will abrogate pause times when administrating the radiotherapy. This will shorten the radiotherapy sessions for lung patients treated with stereotaxis and for breast cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tomotherapy (HFPV vs free breathing)
Arm Type
Experimental
Arm Description
Tomotherapy: locally advanced lung cancer (Stage III) or left breast cancer. High Frequency Percussive Ventilation will be coupled to tomotherapy treatment. The alternative procedure is free breathing.
Arm Title
linear accelerator (HFPV vs ABC)
Arm Type
Experimental
Arm Description
Linear accelerator: breast cancer or pulmonary cancers (Stage I/II) requiring a stereotaxic radiotherapy. High Frequency Percussive Ventilation will be coupled to linear accelerator. The alternative procedure is Active Breathing Control (ABC).
Intervention Type
Device
Intervention Name(s)
High Frequency Percussive Ventilation
Other Intervention Name(s)
HFPV
Intervention Description
High Frequency Percussive Ventilation
Intervention Type
Other
Intervention Name(s)
Free breathing
Intervention Description
Free breathing
Intervention Type
Other
Intervention Name(s)
Active Breathing Control
Other Intervention Name(s)
ABC
Intervention Description
Active Breathing Control
Primary Outcome Measure Information:
Title
HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast)
Description
Radiotherapy treatment fractions (locally advanced lung: 33 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start. Dose distribution will be determined for both situations and patients will be treated with the most favourable one.
Time Frame
0-14 days between registration and treatment start according to standard patient care
Title
HFPV vs ABC: decrease the duration of radiotherapy fractions (lung: 1/2 and breast 1/3)
Description
Lung (5 fractions) or breast (25 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start. The time of fractions administration will be compared to theoretical times of treatment when patient is free breathing (lung 45 min for 12Gy/ breast 10 min for 2Gy).
Time Frame
0-14 days between registration and treatment start according to standard patient care

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: breast cancer eligible for tomotherapy or linear accelerator with ABC system lung cancer eligible for curative tomotherapy and with a significant breathing movements amplitude lung cancer eligible for ablative stereotaxis WHO 0 or 1 Exclusion Criteria: patients requiring oxygen or not able to lie on the back (dyspnea) pulmonary functions altered cardiac insufficiency patient not able to breathe with the High Frequency Ventilation System risk of pneumothorax when experiencing High Frequency Ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Bourhis, Prof
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment

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