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

Radiotherapy Clinical Trial

Official title:

Fractional Exhaled NO, Extended NO Analysis and NO/CO Diffusing Capacity in Patients Receiving Thoracic Radiation Therapy: a Single Centre Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03431740
• Other study ID #: 2017-01374
• Status: Terminated
• Start date: February 15, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiotherapy

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diffusing capacity for carbon monoxide (DLCO)	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
Secondary	Transfer Coefficient for nitric oxide (DLNO/VA)	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
Secondary	Transfer Coefficient for carbon monoxide (DLCO/VA)	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
Secondary	Ratio of DLNO and DLCO	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
Secondary	Alveolar-capillary membrane-diffusing capacity for carbon monoxide (DMCO)	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
Secondary	Pulmonary capillary blood volume (Vc)	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
Secondary	Alveolar Volume (VA)	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
Secondary	Fractional concentration of exhaled nitric oxide at a flow rate of 50mL/s (FENO50)	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
Secondary	Concentration of nitric oxide in the gas phase of the alveolar or acinar region (CANO)	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
Secondary	Tissue concentration of nitric oxide of the airway wall (CawNO)	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
Secondary	Airway compartment diffusing capacity of nitric oxide from the of of the airway wall to the gas stream (DawNO)	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
Secondary	Total flux of nitric oxide in the conducting airway compartment (JawNO)	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
Secondary	Forced expiratory volume in 1 second	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
Secondary	Forced vital capacity	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
Secondary	Forced expiratory flow between 25% and 75% of forced vital capacity	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