NCT03431740

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

3.1 years

First QC Date

January 18, 2018

Last Update Submit

April 16, 2021

Conditions

Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +10 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • planned but not already commenced radiation therapy (RT) of the chest, with or without pre-RT surgery.
  • signed informed consent of the participant

You may not qualify if:

  • thoracic RT in the past
  • treatment with immune checkpoint inhibitors
  • unstable condition affecting participation in the measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2018

First Posted

February 13, 2018

Study Start

February 15, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)