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

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

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 Zürich

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

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

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

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

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)

February 15, 2018

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID 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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