Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploratory Study on Therapy for Breath Hold in Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03729661
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 5, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE April 18, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
Completing proportion (Tolerability) [ Time Frame: 40 days ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Tolerability of the treatment [ Time Frame: 90 seconds ]
Can patients hold their breath for the minimum of 90 seconds, measured with a stopwatch
Change History Complete list of historical versions of study NCT03729661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Poroportion of patients able to complete breathhold during training [ Time Frame: 90 seconds ]
    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.
  • Investigation of the stability of a breath hold. Breath hold is considered stable if the variations during a breath hold are within 3 mm. [ Time Frame: 90 seconds ]
    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.
  • Reproduciblity of the breath hold [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]
    The difference between the baseline chest position (during planning breath hold CT scan) and breath hold during each fraction.
  • Subjective tolerance as commented by volunteers [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]
    Comments of volunteers after the test will be recorded as free text.
  • Subjective tolerance [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]
    Comments of volunteers after the test will be recorded
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Poroportion of patients able to complete breathhold during training [ Time Frame: 90 seconds ]
    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.
  • Investigation of the stability of a breath hold. Breath hold is considered stable if the variations during a breath hold are within 3 mm. [ Time Frame: 90 seconds ]
    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.
  • Reproduciblity of the breath hold [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]
    The difference between the baseline chest position (during planning breath hold CT scan) and breath hold during each fraction.
  • Subjective tolerance as commented by volunteers [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]
    Comments of volunteers after the test will be recorded as free text.
  • Subjective tolerance [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]
    Comments of volunteers after the test will be recorded as the patients rate items on a 5-point scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study on Therapy for Breath Hold in Radiotherapy
Official Title  ICMJE Exploratory Study on Nasal High Flow Therapy for Breath Hold in Radiotherapy.
Brief 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. 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Exploratory study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Breast Cancer
Intervention  ICMJE Behavioral: Nasal High Flow Therapy
Use of Nasal High Flow Therapy during CT and treatment
Study Arms  ICMJE Experimental: Breath hold
Patients who receive a breathhold CT- and treatment
Intervention: Behavioral: Nasal High Flow Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient refusal
  • Hypercapnic COPD patient (= arterial carbon dioxide tension PaCO2 > 45 mmHg)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chantal Overhof-Wedick +31 88 4455686 chantal.overhof@maastro.nl
Contact: Sylvie Canisius +31 88 4455638 sylvie.canisius@maastro.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729661
Other Study ID Numbers  ICMJE ENTheR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maastricht Radiation Oncology
Study Sponsor  ICMJE Maastricht Radiation Oncology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stéphanie Peeters Maastro Clinic, The Netherlands
Principal Investigator: Gloria Vilches Maastro Clinic, The Netherlands
PRS Account Maastricht Radiation Oncology
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP