Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Not Applicable

Terminated

• Conditions: Pneumonitis; Nonsmall Cell Lung Cancer Stage III

• Registration Number: NCT04040244
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.

Detailed Description

Primary Objective:

• To quantify the intra-person variability of concentrations of TGF-β1, IL-6, IL-1α, and IL-10 measured in exhaled breath condensate.

Secondary Objectives:

* To examine the associations between differences in pre-treatment and post-treatment exhaled breath condensate concentrations of TGF-β1, IL-6, IL-1α, and IL-10 and the development of CTCAE grade 2+ symptomatic pneumonitis.

* To examine the associations between serum measures of TGF-β1, IL-6, IL-1α, and IL-10 and:

* Exhaled breath condensate measures of the same biomarkers, and

* The development of CTCAE grade 2+ symptomatic pneumonitis.

* To examine the association between microbiome signatures found in pre-treatment exhaled breath condensate and the development of CTCAE grade 2+ symptomatic pneumonitis.

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Study Start: 2019-12-09
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Status Verified: 2023-08
• Results First Submitted: 2023-08-08
• Results First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Results First Posted: 2023-10-11
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age greater than or equal to 18 years old.
• Clinically diagnosed or suspected Stage III non-small cell lung cancer to be treated with chemoradiotherapy as part of cancer treatment, as determined by the treating clinician.
• Plan for treatment with definitive radiotherapy (≥60 Gy) with concurrent chemotherapy at the discretion of the treating radiation and medical oncologists.
• Willing and able to tolerate exhaled breath collection.
• Able to provide informed consent.

Exclusion Criteria

• Systemic (oral, intravenous or intramuscular) corticosteroid use for any reason within 5 days of registration.
• Prior radiotherapy directed at the chest (thoracic inlet superiorly to diaphragm inferiorly).
• Any systemic antibiotic use within 2 weeks of registration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variability of Biomarkers	At baseline and one month after completion of chemotherapy	Concentrations of TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) will be measured in exhaled breath condensate at baseline, at 2 weeks and after chemotherapy start and 6 weeks after chemotherapy start (the end of chemotherapy) and 1 month after completion of chemotherapy using a 2-tailed alpha of 0.05 with detectable standard deviation units from baseline to post treatment.

Secondary Outcome Measures

Name	Time	Method
Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT	One month after completion of chemotherapy	TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) measured in exhaled breath condensate to compare mean change levels from (baseline), at 2 weeks after CRT start, 6-weeks after CRT start (the end of CRT), and 1 month after completion of chemotherapy using t-tests comparing mean change levels in each marker.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States