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

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ClinicalTrials.gov Identifier: NCT03431740
Recruitment Status : Suspended (Study recruitment paused due to Corona-Pandemic)
First Posted : February 13, 2018
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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
Radiotherapy

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Study Type : Observational
Estimated Enrollment : 38 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 : February 15, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431740


Locations
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Switzerland
University Hospital of Zurich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03431740    
Other Study ID Numbers: 2017-01374
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No