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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03431740

Enrollment

Registered

2018-02-13

Start date

2018-02-15

Completion date

2021-04-01

Last updated

2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapy

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Countries

Switzerland

Outcome results