Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Wake Forest University Health Sciences16 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pneumonitis Nonsmall Cell Lung Cancer Stage III

Interventions

Exhaled Breath CollectionOTHER

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 sampleOTHER

Blood samples collected simultaneously with routine standard of care blood draws.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Variability of Biomarkers

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.

Time frame: At baseline and one month after completion of chemotherapy

Secondary Outcomes

Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT

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.

Time frame: One month after completion of chemotherapy

Data from ClinicalTrials.gov

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