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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02936947
• Other study ID #: CHUV-DO-PART-2016
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 21, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer

Intervention

Device:
• High Frequency Percussive Ventilation
High Frequency Percussive Ventilation

Other:
• Free breathing
Free breathing
• Active Breathing Control
Active Breathing Control

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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