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

Sponsor
University of Zurich (Other)
Overall Status
Terminated
CT.gov ID
NCT03431740
Collaborator
(none)
3
Enrollment
1
Location
37.5
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Fractional Exhaled NO, Extended NO Analysis and NO/CO Diffusing Capacity in Patients Receiving Thoracic Radiation Therapy: a Single Centre Study
    Actual Study Start Date :
    Feb 15, 2018
    Actual Primary Completion Date :
    Apr 1, 2021
    Actual Study Completion Date :
    Apr 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Change in diffusing capacity for nitric oxide (DLNO) [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

    1. Diffusing capacity for carbon monoxide (DLCO) [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.

    2. Transfer Coefficient for nitric oxide (DLNO/VA) [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.

    3. Transfer Coefficient for carbon monoxide (DLCO/VA) [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.

    4. Ratio of DLNO and DLCO [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.

    5. Alveolar-capillary membrane-diffusing capacity for carbon monoxide (DMCO) [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.

    6. Pulmonary capillary blood volume (Vc) [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.

    7. Alveolar Volume (VA) [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.

    8. Fractional concentration of exhaled nitric oxide at a flow rate of 50mL/s (FENO50) [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.

    9. Concentration of nitric oxide in the gas phase of the alveolar or acinar region (CANO) [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.

    10. Tissue concentration of nitric oxide of the airway wall (CawNO) [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.

    11. Airway compartment diffusing capacity of nitric oxide from the of of the airway wall to the gas stream (DawNO) [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.

    12. Total flux of nitric oxide in the conducting airway compartment (JawNO) [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.

    13. Forced expiratory volume in 1 second [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.

    14. Forced vital capacity [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.

    15. Forced expiratory flow between 25% and 75% of forced vital capacity [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Zurich Zürich Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT03431740
    Other Study ID Numbers:
    • 2017-01374
    First Posted:
    Feb 13, 2018
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 20, 2021