Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

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

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.

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.