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

• ClinicalTrials.gov Identifier: NCT03431740
• Recruitment Status: Suspended
• First Posted: February 13, 2018
• Last Update Posted: December 22, 2020
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

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
Radiotherapy

Study Design

• 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

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Switzerland

University Hospital of Zurich

Zürich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

More Information

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT03431740
• Other Study ID Numbers: 2017-01374
• First Posted: February 13, 2018
• Last Update Posted: December 22, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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