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

Vaud University Hospital Center

Status: Terminated

Conditions: Breast Cancer; Lung Cancer

Treatments: Device: High Frequency Percussive Ventilation; Other: Active Breathing Control; Other: Free breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT02936947

CHUV-DO-PART-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

tomotherapy (HFPV vs free breathing)

Experimental group

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.

Treatment:

Device: High Frequency Percussive Ventilation

Other: Free breathing

linear accelerator (HFPV vs ABC)

Experimental group

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).

Treatment:

Other: Active Breathing Control

Device: High Frequency Percussive Ventilation