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

NCT02936947 | Terminated

• 1 other identifier: CHUV-DO-PART-2016
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

tomotherapy (HFPV vs free breathing)

EXPERIMENTAL

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; Other: Free breathing

linear accelerator (HFPV vs ABC)

EXPERIMENTAL

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; Other: Active Breathing Control

Interventions

High Frequency Percussive Ventilation DEVICE

High Frequency Percussive Ventilation

Also known as: HFPV

linear accelerator (HFPV vs ABC); tomotherapy (HFPV vs free breathing)

Free breathing OTHER

Free breathing

tomotherapy (HFPV vs free breathing)

Active Breathing Control OTHER

Active Breathing Control

Also known as: ABC

linear accelerator (HFPV vs ABC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean Bourhis, Prof

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of radio-oncology

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: October 18, 2016
• Study Start: July 1, 2016
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)