FENO, Extended NO Analysis and NO/CO Diffusing Capacity in Thoracic Radiation Therapy

April 16, 2021 updated by: University of Zurich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • planned but not already commenced radiation therapy (RT) of the chest, with or without pre-RT surgery.
  • signed informed consent of the participant

Exclusion Criteria:

  • thoracic RT in the past
  • treatment with immune checkpoint inhibitors
  • unstable condition affecting participation in the measurements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
This variable is a calculated variable. The course over time will be described.
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
This variable is a calculated variable. The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
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
The course over time will be described.
Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-01374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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