Exhaled Breath Analysis for the Prediction of Symptomatic Pneumonitis Risk after Chemoradiotherapy in Patients with Stage III Non-small Cell Lung Cancer

PRIMARY OBJECTIVE:

I. To quantify the intra-person variability of concentrations of tumor growth factor (TGF)-beta1, interleukin (IL)-6, IL-1alpha, and IL-10 measured in exhaled breath condensate.

SECONDARY OBJECTIVES:

I. To examine the associations between differences in pre-treatment and post-treatment exhaled breath condensate (EBC) concentrations of TGF-beta1, IL-6, IL-1alpha, and IL-10 and the development of Common Terminology Criteria for Adverse Events (CTCAE) grade 2+ symptomatic pneumonitis (SP).

II. To examine the associations between serum measures of TGF-beta1, IL-6, IL-1alpha, and IL-10 and:

IIa. EBC measures of the same biomarkers, and

IIb. The development of CTCAE grade 2+ SP.

III. To examine the association between microbiome signatures found in pre-treatment EBC and the development of CTCAE grade 2+ SP.

EXPLORATORY OBJECTIVE:

I. To examine the association between pre- and post-treatment exhaled breath volatile-based metabolites and the development of SP.

OUTLINE:

Patients undergo collection of exhaled breath over 10 minutes for condensate and over 5-7 minutes for volatiles prior to chemoradiotherapy (CRT) start, 2 and 6 weeks after CRT start, and 1 month after CRT completion. Patients also undergo collection of blood samples prior to CRT start, 2 and 6 weeks after CRT start, and 1 month after CRT completion.

After the completion of study, patients are followed up at 1 and 4 months.