Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Pneumonitis Clinical Trial

Official title:

A Pilot Study of Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis After Chemoradiotherapy For Stage III Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04040244
• Other study ID #: IRB00059924
• Secondary ID: WFBCCC 98119NCI-
• Status: Terminated
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: March 10, 2022

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer Stage III
• Pneumonia
• Pneumonitis

Intervention

Other:
• Exhaled Breath Collection
Exhaled breath condensate (EBC) and exhaled breath volatiles (EBV) samples will be obtained over 5-10 minutes using a one-time use R-tube apparatus.
• Blood sample
Blood samples collected simultaneously with routine standard of care blood draws.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of Biomarkers	Concentrations of TGF-ß1, IL-6, IL-1a, 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.	At baseline and one month after completion of chemotherapy
Secondary	Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT	TGF-ß1, IL-6, IL-1a, 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.	One month after completion of chemotherapy