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

Not Applicable

Terminated

• Conditions: Breast Cancer; Lung Cancer
• Interventions: Device: High Frequency Percussive Ventilation; Other: Active Breathing Control; Other: Free breathing

• Registration Number: NCT02936947
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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 :

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-10-15
• Study First Posted: 2016-10-18
• Primary Completion: 2021-12-21
• Study Completion: 2021-12-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linear accelerator (HFPV vs ABC)	High Frequency Percussive Ventilation	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).
linear accelerator (HFPV vs ABC)	Active Breathing Control	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).
tomotherapy (HFPV vs free breathing)	High Frequency Percussive Ventilation	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.
tomotherapy (HFPV vs free breathing)	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.

Primary Outcome Measures

Name	Time	Method
HFPV vs ABC: decrease the duration of radiotherapy fractions (lung: 1/2 and breast 1/3)	0-14 days between registration and treatment start according to standard patient care	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).
HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast)	0-14 days between registration and treatment start according to standard patient care	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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland