Nonsmall Cell Lung Cancer Stage III, Pneumonitis
Conditions
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.
Interventions
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.
OTHERBlood sample
Blood samples collected simultaneously with routine standard of care blood draws.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exhaled Breath Analysis Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes.
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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Exhaled Breath Analysis |
|---|---|
| Age, Continuous | 65.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 5 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
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
Population: 9 have data at baseline; 6 have data at 1 month post CRT (chemo-radiation treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exhaled Breath Analysis | Variability of Biomarkers | TGF-b1 baseline | 87.84 ng/mL | Standard Deviation 15.94 |
| Exhaled Breath Analysis | Variability of Biomarkers | TGF-b1 1 month post CRT | 100.47 ng/mL | Standard Deviation 21.9 |
| Exhaled Breath Analysis | Variability of Biomarkers | IL-6 baseline | 5.39 ng/mL | Standard Deviation 2.49 |
| Exhaled Breath Analysis | Variability of Biomarkers | IL-6 1 month post CRT | 6.96 ng/mL | Standard Deviation 1.11 |
| Exhaled Breath Analysis | Variability of Biomarkers | IL-10 baseline | 136.91 ng/mL | Standard Deviation 19.85 |
| Exhaled Breath Analysis | Variability of Biomarkers | IL-10 1 month post CRT | 151.07 ng/mL | Standard Deviation 26.99 |
| Exhaled Breath Analysis | Variability of Biomarkers | IL-1a baseline | 2.41 ng/mL | Standard Deviation 2.52 |
| Exhaled Breath Analysis | Variability of Biomarkers | IL-1a 1 month post CRT | 2.36 ng/mL | Standard Deviation 9.72 |
Secondary
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
Population: 6 participants who had relevant data at both required time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exhaled Breath Analysis | Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT | TGF-b1 mean diff | 14.81 ng/mL | Standard Deviation 18.17 |
| Exhaled Breath Analysis | Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT | IL-6 mean diff | 1.03 ng/mL | Standard Deviation 2.34 |
| Exhaled Breath Analysis | Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT | IL-10 mean diff | 18.62 ng/mL | Standard Deviation 24.15 |
| Exhaled Breath Analysis | Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT | IL-1a mean diff | 2.36 ng/mL | Standard Deviation 9.72 |