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

NCT ID: NCT02936947

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2021-12-21

Brief Summary

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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

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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.

Conditions

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Lung Cancer Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High Frequency Percussive Ventilation

Intervention Type DEVICE

High Frequency Percussive Ventilation

Free breathing

Intervention Type OTHER

Free breathing

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).

Group Type EXPERIMENTAL

High Frequency Percussive Ventilation

Intervention Type DEVICE

High Frequency Percussive Ventilation

Active Breathing Control

Intervention Type OTHER

Active Breathing Control

Interventions

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High Frequency Percussive Ventilation

High Frequency Percussive Ventilation

Intervention Type DEVICE

Free breathing

Free breathing

Intervention Type OTHER

Active Breathing Control

Active Breathing Control

Intervention Type OTHER

Other Intervention Names

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HFPV ABC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Jean Bourhis

Head of radio-oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Bourhis, Prof

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

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Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CHUV-DO-PART-2016

Identifier Type: -

Identifier Source: org_study_id

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