Lung CancerNCT02936947
Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment
A study testing High Frequency Percussive Ventilation and Free breathing in people with Lung Cancer and Breast Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Breast Cancer
- What is being tested?
- High Frequency Percussive Ventilation and Free breathing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Primary objective :
Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :
- 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 .
- 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.
- Conditions
- Lung Cancer, Breast Cancer
- Being tested
- High Frequency Percussive Ventilation, Free breathing, Active Breathing Control
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Percussive VentilationDevice
Also called HFPV
High Frequency Percussive Ventilation
Free breathingOther
Free breathing
Active Breathing ControlOther
Also called ABC
Active Breathing Control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: High Frequency Percussive Ventilation; Other: Active Breathing Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 0-14 days between registration and treatment start according to standard patient care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJul 2016
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Why it stopped: due to Covid19 restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Bourhis, Centre Hospitalier Universitaire Vaudois
- Investigators
- Jean Bourhis, Prof, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936947
- Sponsor's protocol ID
- CHUV-DO-PART-2016
- Status last verified
- Mar 2022
- First submitted
- 30 Aug 2016
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment
- ClinicalTrials.gov ID
- NCT02936947
- Acronym / sponsor ID
- CHUV-DO-PART-2016
- Conditions
- Lung Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to Covid19 restrictions
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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 .
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tomotherapy (HFPV vs free breathing) | Experimental | Device: High Frequency Percussive Ventilation, Other: Free breathingTomotherapy: 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. |
| linear accelerator (HFPV vs ABC) | Experimental | Device: High Frequency Percussive Ventilation, Other: Active Breathing ControlLinear 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Frequency Percussive VentilationAlso: HFPVHigh Frequency Percussive Ventilation | Device | linear accelerator (HFPV vs ABC), tomotherapy (HFPV vs free breathing) |
| Free breathingFree breathing | Other | tomotherapy (HFPV vs free breathing) |
| Active Breathing ControlAlso: ABCActive Breathing Control | Other | linear accelerator (HFPV vs ABC) |
Primary outcome
HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast)
Time frame: 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.
HFPV vs ABC: decrease the duration of radiotherapy fractions (lung: 1/2 and breast 1/3)
Time frame: 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).
Results and safety
The study was stopped early (reason given: due to Covid19 restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Bourhis, Prof principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Percussive Ventilation and Free breathing in people with Lung Cancer and Breast Cancer, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to Covid19 restrictions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFPV vs free breathing: 1/3 decrease of V20 (lung) or 1/2 decrease of Dmax (breast) (time frame: 0-14 days between registration and treatment start according to standard patient care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.