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TerminatedNCT02936947Updated Mar 24, 2022

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

An interventional study of High Frequency Percussive Ventilation and Free breathing in Lung Cancer and Breast Cancer, sponsored by Centre Hospitalier Universitaire Vaudois. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-24.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment

Why this study was terminated
due to Covid19 restrictions
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Primary objective :

Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :

  1. 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 .
  2. 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.
02

Conditions studied

  • Lung Cancer
  • Breast Cancer
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 8 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

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Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    tomotherapy (HFPV vs free breathing)

    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.

    Device: High Frequency Percussive Ventilation · Other: Free breathing

  • Experimental
    linear accelerator (HFPV vs ABC)

    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).

    Device: High Frequency Percussive Ventilation · Other: Active Breathing Control

Interventions

  • DeviceHigh Frequency Percussive Ventilation

    High Frequency Percussive Ventilation

    Also known as: HFPV

  • OtherFree breathing

    Free breathing

  • OtherActive Breathing Control

    Active Breathing Control

    Also known as: ABC

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-14 days between registration and treatment start according to standard patient care

  2. 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).

    Time frame: 0-14 days between registration and treatment start according to standard patient care

07

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, 1011, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in Dec 2021, 65 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2016
First posted
Oct 18, 2016
StartActual
Jul 2016
Primary completionActual
Dec 21, 2021
CompletionActual
Dec 21, 2021
Last update
Mar 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02936947
Responsible party
Jean Bourhis (Head of radio-oncology, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Oct 18, 2016
Start date
Jul 2016
Primary completion
Dec 21, 2021
Completion
Dec 21, 2021
Last update
Mar 24, 2022

Study contacts

Jean Bourhis, Prof
principal investigator · CHUV

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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