RadiotherapyNCT03431740
FENO, Extended NO Analysis and NO/CO Diffusing Capacity in Thoracic Radiation Therapy
An observational study of Radiotherapy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The investigators aim to investigate the impact of thoracic radiation therapy on diffusion capacity of the lung (primary endpoint: diffusion capacity for nitric oxide, DLNO) and on exhaled nitric oxide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2018to 1 Apr 2021
- Phase
- Observational
- 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
Study population: The study population consists in patients with planned but not already commenced radiation therapy of the chest. Recruitment will be performed at the Radiation Oncology Clinic at University Hospital of Zurich.
Who may be able to join
- planned but not already commenced radiation therapy (RT) of the chest, with or without pre-RT surgery.
- signed informed consent of the participant
Who cannot join
- thoracic RT in the past
- treatment with immune checkpoint inhibitors
- unstable condition affecting participation in the measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional Exhaled NO, Extended NO Analysis and NO/CO Diffusing Capacity in Patients Receiving Thoracic Radiation Therapy: a Single Centre Study
The investigators aim to investigate the impact of thoracic radiation therapy on diffusion capacity of the lung (primary endpoint: diffusion capacity for nitric oxide, DLNO) and on exhaled nitric oxide.
- Conditions
- Radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diffusing capacity for nitric oxide (DLNO)
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Secondary outcomes (15)
Diffusing capacity for carbon monoxide (DLCO)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Transfer Coefficient for nitric oxide (DLNO/VA)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Transfer Coefficient for carbon monoxide (DLCO/VA)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Ratio of DLNO and DLCO
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Alveolar-capillary membrane-diffusing capacity for carbon monoxide (DMCO)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Pulmonary capillary blood volume (Vc)
This variable is a calculated variable. The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Alveolar Volume (VA)
This variable is a calculated variable. The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Fractional concentration of exhaled nitric oxide at a flow rate of 50mL/s (FENO50)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Concentration of nitric oxide in the gas phase of the alveolar or acinar region (CANO)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Tissue concentration of nitric oxide of the airway wall (CawNO)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Airway compartment diffusing capacity of nitric oxide from the of of the airway wall to the gas stream (DawNO)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Total flux of nitric oxide in the conducting airway compartment (JawNO)
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Forced expiratory volume in 1 second
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Forced vital capacity
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Forced expiratory flow between 25% and 75% of forced vital capacity
The course over time will be described.
Measured: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start15 Feb 2018
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431740
- Sponsor's protocol ID
- 2017-01374
- Other IDs
- 2017
- Status last verified
- Apr 2021
- First submitted
- 18 Jan 2018
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Exhaled NO, Extended NO Analysis and NO/CO Diffusing Capacity in Patients Receiving Thoracic Radiation Therapy: a Single Centre Study
- ClinicalTrials.gov ID
- NCT03431740
- Acronym / sponsor ID
- 2017-01374
- Conditions
- Radiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 Feb 2018 (actual)
- 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.
The investigators aim to investigate the impact of thoracic radiation therapy on diffusion capacity of the lung (primary endpoint: diffusion capacity for nitric oxide, DLNO) and on exhaled nitric oxide.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists in patients with planned but not already commenced radiation therapy of the chest. Recruitment will be performed at the Radiation Oncology Clinic at University Hospital of Zurich.
Key inclusion criteria (2 listed)
- planned but not already commenced radiation therapy (RT) of the chest, with or without pre-RT surgery.
- signed informed consent of the participant
Key exclusion criteria (3 listed)
- thoracic RT in the past
- treatment with immune checkpoint inhibitors
- unstable condition affecting participation in the measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in diffusing capacity for nitric oxide (DLNO)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
15 secondary outcomes
Diffusing capacity for carbon monoxide (DLCO)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Transfer Coefficient for nitric oxide (DLNO/VA)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Transfer Coefficient for carbon monoxide (DLCO/VA)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Ratio of DLNO and DLCO
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Alveolar-capillary membrane-diffusing capacity for carbon monoxide (DMCO)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Pulmonary capillary blood volume (Vc)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Alveolar Volume (VA)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Fractional concentration of exhaled nitric oxide at a flow rate of 50mL/s (FENO50)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Concentration of nitric oxide in the gas phase of the alveolar or acinar region (CANO)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Tissue concentration of nitric oxide of the airway wall (CawNO)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Airway compartment diffusing capacity of nitric oxide from the of of the airway wall to the gas stream (DawNO)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Total flux of nitric oxide in the conducting airway compartment (JawNO)
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Forced expiratory volume in 1 second
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Forced vital capacity
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Forced expiratory flow between 25% and 75% of forced vital capacity
Time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy, run by University of Zurich 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 2 inclusion and 3 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 20 Apr 2021. 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: Insufficient recruitment). 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?
Change in diffusing capacity for nitric oxide (DLNO) (time frame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT). 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 20 Apr 2021.