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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Lung Cancer
• Intervention / Treatment: Device: High Frequency Percussive Ventilation; Other: Free breathing; Other: Active Breathing Control

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; High Frequency Percussive Ventilation; Other Names: HFPV; Other: Free breathing; 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; High Frequency Percussive Ventilation; Other Names: HFPV; Other: Active Breathing Control; Active Breathing Control; Other Names: ABC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-14 days between registration and treatment start according to standard patient care
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).	0-14 days between registration and treatment start according to standard patient care

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Jean Bourhis, Prof, CHUV

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: October 15, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CHUV-DO-PART-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No