Clinical trial NCT03431740: FENO, Extended NO Analysis and NO/CO Diffusing Capacity in Thoracic Radiation Therapy
Official title: Fractional Exhaled NO, Extended NO Analysis and NO/CO Diffusing Capacity in Patients Receiving Thoracic Radiation Therapy: a Single Centre Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Radiotherapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Change in diffusing capacity for nitric oxide (DLNO)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Secondary outcomes:
measure: Diffusing capacity for carbon monoxide (DLCO)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Transfer Coefficient for nitric oxide (DLNO/VA)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Transfer Coefficient for carbon monoxide (DLCO/VA)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Ratio of DLNO and DLCO
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Alveolar-capillary membrane-diffusing capacity for carbon monoxide (DMCO)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Pulmonary capillary blood volume (Vc)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Alveolar Volume (VA)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Fractional concentration of exhaled nitric oxide at a flow rate of 50mL/s (FENO50)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Concentration of nitric oxide in the gas phase of the alveolar or acinar region (CANO)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Tissue concentration of nitric oxide of the airway wall (CawNO)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Airway compartment diffusing capacity of nitric oxide from the of of the airway wall to the gas stream (DawNO)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Total flux of nitric oxide in the conducting airway compartment (JawNO)
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Forced expiratory volume in 1 second
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Forced vital capacity
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
measure: Forced expiratory flow between 25% and 75% of forced vital capacity
timeFrame: Before start of radiation therapy (RT), at the day of end of RT, 6 weeks and 12 months after end of RT
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
References: