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Lung CancerNCT03729661

Exploratory Study on Therapy for Breath Hold in Radiotherapy

A study testing Nasal High Flow Therapy in people with Lung Cancer and Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Due to breathing and other motions, tumours, such as breast and lung cancer, as well as their surrounding organs (e.g. the heart), move, which poses a challenge for radiotherapy treatment. Reducing or even stopping breathing, e.g. 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?
Nasal High Flow Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNetherlands
Study dates
18 Apr 2019to 3 Jan 2020
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

  • Locally advanced lung cancer or oligometastatic patients with "local" stage III, treated with curative or radical intent OR
  • Left-sided breast cancer patients treated with radiotherapy with curative intent.
  • WHO≤ 2
  • ≥ 18 years old
  • Able to give informed consent

Who cannot join

  • Patient refusal
  • Hypercapnic COPD patient (= arterial carbon dioxide tension PaCO2 > 45 mmHg)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Maastricht Radiation Oncology

    Maastricht, 6202 AZ

Other trials in Netherlands

About this study

Official title: Exploratory Study on Nasal High Flow Therapy for Breath Hold in Radiotherapy.

Due to breathing and other motions, tumours, such as breast and lung cancer, as well as their surrounding organs (e.g. the heart), move, which poses a challenge for radiotherapy treatment. Reducing or even stopping breathing, e.g. by irradiating during inspiration, is a way to decrease tumour and organ motion resulting in a reliable target coverage with smaller margins. These smaller margins can result in a better sparing of normal tissues. Furthermore, in some patients, during inspiration, the heart may move away from the target volume making it possible to better spare the heart. Finally, during inspiration, the lung volume is larger and the lung density is lower, which can lead to a lower dose to the surrounding normal lung tissue. Reduction of radiation dose to normal tissues leads to less radiation-induced toxicity. This makes treating breast and lung cancer patients in breath hold (BH) conditions an attractive strategy. Standard BH durations in RT treatment are around 20 seconds, which is not enough to perform a complete CBCT. The health status of lung cancer patients is generally worse compared to breast cancer patients, making it more difficult to treat this patient group during breath hold. Nasal High Flow Therapy (NHFT) is a non-invasive system that provides controlled oxygen concentrations and low levels of positive pressure via a nasal interface. NHFT improves oxygenation in diverse patient groups, and is increasingly used as an alternative to mechanical ventilatory support. It has been shown to be a safe device in several clinical situations and patient populations, such as COPD patients, but also in apneic conditions under general anesthesia.

Read the detailed description

Due to breathing and other motion, tumours, such as breast and lung cancer, as well as their surrounding organs (e.g. the heart), move, which poses a challenge for radiotherapy treatment. Reducing or even stopping breathing, e.g. by irradiating during inspiration, is a way to decrease tumor and organ motion resulting in a reliable target coverage with smaller margins. These smaller margins can result in a better sparing of normal tissues. Furthermore, in some patients, during inspiration, the heart may move away from the target volume making it possible to better spare the heart. Finally, during inspiration, the lung volume is larger and the lung density is lower, which can lead to a lower dose to the surrounding normal lung tissue. Reduction of radiation dose to normal tissues leads to less radiation-induced toxicity. This makes treating breast and lung cancer patients in breath hold (BH) conditions an attractive strategy. A BH has to be stable and long enough for the duration of a planning CT-scan, cone beam CT (CBCT) scan and treatment delivery. Treatment of left-sided breast cancer with radiotherapy in moderate deep inspiration breath hold (mDIBH) is well established. Also, in MAASTRO clinic, left-sided breast cancer patients are treated in mDIBH, but this is done without any support or control of the breath hold. Standard BH durations in RT treatment are around 20 seconds, which is not enough to perform a complete CBCT. The health status of lung cancer patients is generally worse compared to breast cancer patients, making it more difficult to treat this patient group during breath hold. mDIBH in lung cancer patients is therefore not widely used, and not yet performed in MAASTRO clinic. Ventilation techniques that can support patients in holding their breath might make it a feasible approach in patients with a less favourable performance status, and might increase the duration of a breath hold. Nasal High Flow Therapy (NHFT) is a non-invasive system that provides controlled oxygen concentrations and low levels of positive pressure via a nasal interface. NHFT improves oxygenation in diverse patient groups, and is increasingly used as an alternative to mechanical ventilatory support. It has been shown to be a safe device in several clinical situations and patient populations, such as COPD patients, but also in apneic conditions under general anesthesia. It has however never been used in the context of breath hold support, neither has it been used in radiotherapy practice. The investigators hypothesize that supporting BH with nasal high flow therapy (NHFT) will allow robust radiotherapy treatments of moving targets in a broad patient population allowing for BHs that are long enough, stable and reproducible during a whole treatment course.

Being tested
Nasal High Flow Therapy
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.

  • Nasal High Flow TherapyBehavioural

    Use of Nasal High Flow Therapy during CT and treatment

Study groups in NCT03729661
Study groupRoleWhat they receive
Breath holdExperimentalPatients who receive a breathhold CT- and treatment
Receives: Behavioral: Nasal High Flow Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completing proportion (Tolerability)

    The proportion of patients completing the treatment (CT-scan and alle treatment sessions) in breath hold conditions using nasal high flow therapy (Tolerability of the treatment)

    Measured: 40 days

Secondary outcomes (5)
  1. Poroportion of patients able to complete breathhold during training

    Proportion of patients in the population, able to do at least one breath hold of at least 90 seconds during the training session, measured by counting the absolute number of patients.

    Measured: 90 seconds

  2. Investigation of the stability of a breath hold. Breath hold is considered stable if the variations during a breath hold are within 3 mm.

    Investigation of the stability of a breath hold, the position of the chest during the whole duration of the breath hold, monitored by the surface guidance system, installed in the CT and treatment room. Breath hold is considered stable if the variations during a breath hold are within 3 mm.

    Measured: 90 seconds

  3. Reproduciblity of the breath hold

    The difference between the baseline chest position (during planning breath hold CT scan) and breath hold during each fraction.

    Measured: Overall radiation treatment schedule, varies up to 4 weeks.

  4. Subjective tolerance as commented by volunteers

    Comments of volunteers after the test will be recorded as free text.

    Measured: Overall radiation treatment schedule, varies up to 4 weeks.

  5. Subjective tolerance

    Comments of volunteers after the test will be recorded

    Measured: Overall radiation treatment schedule, varies up to 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2018
  2. Study start18 Apr 2019
  3. Primary completion3 Jan 2020
  4. Study completion3 Jan 2020

Resources

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
Not applicable
Intervention model
Single group
Model description
Exploratory study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03729661
Sponsor's protocol ID
ENTheR
Status last verified
Dec 2019
First submitted
29 Oct 2018
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nasal High Flow Therapy in people with Lung Cancer and Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.

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 5 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jan 2020. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Completing proportion (Tolerability) (time frame: 40 days). 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 18 Jan 2020.

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Clinical Trial NCT03729661 | AzTrials