Trial Outcomes & Findings for Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis (NCT NCT04040244)
NCT ID: NCT04040244
Last Updated: 2023-10-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
At baseline and one month after completion of chemotherapy
Results posted on
2023-10-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis
Baseline characteristics by cohort
| Measure |
Exhaled Breath Analysis
n=16 Participants
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.
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|---|---|
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Age, Continuous
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65.6 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At baseline and one month after completion of chemotherapyPopulation: 9 have data at baseline; 6 have data at 1 month post CRT (chemo-radiation treatment)
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.
Outcome measures
| Measure |
Exhaled Breath Analysis
n=9 Participants
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.
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|---|---|
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Variability of Biomarkers
IL-6 baseline
|
5.39 ng/mL
Standard Deviation 2.49
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|
Variability of Biomarkers
IL-6 1 month post CRT
|
6.96 ng/mL
Standard Deviation 1.11
|
|
Variability of Biomarkers
TGF-b1 baseline
|
87.84 ng/mL
Standard Deviation 15.94
|
|
Variability of Biomarkers
TGF-b1 1 month post CRT
|
100.47 ng/mL
Standard Deviation 21.90
|
|
Variability of Biomarkers
IL-10 baseline
|
136.91 ng/mL
Standard Deviation 19.85
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Variability of Biomarkers
IL-10 1 month post CRT
|
151.07 ng/mL
Standard Deviation 26.99
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Variability of Biomarkers
IL-1a baseline
|
2.41 ng/mL
Standard Deviation 2.52
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Variability of Biomarkers
IL-1a 1 month post CRT
|
2.36 ng/mL
Standard Deviation 9.72
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SECONDARY outcome
Timeframe: One month after completion of chemotherapyPopulation: 6 participants who had relevant data at both required time points
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.
Outcome measures
| Measure |
Exhaled Breath Analysis
n=6 Participants
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.
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|---|---|
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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
|
|
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
|
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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
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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
|
Adverse Events
Exhaled Breath Analysis
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exhaled Breath Analysis
n=16 participants at risk
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.
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|---|---|
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Vascular disorders
Hypotension
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6.2%
1/16 • Number of events 1 • 6 months
|
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Cardiac disorders
Cardiac arrest
|
6.2%
1/16 • Number of events 1 • 6 months
|
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Gastrointestinal disorders
Gastrointestional hemorrhage
|
6.2%
1/16 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Exhaled Breath Analysis
n=16 participants at risk
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.
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|---|---|
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Cardiac disorders
Cardiac disorders
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6.2%
1/16 • Number of events 1 • 6 months
|
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Gastrointestinal disorders
Esophagitis
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12.5%
2/16 • Number of events 2 • 6 months
|
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Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
2/16 • Number of events 2 • 6 months
|
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Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
2/16 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
3/16 • Number of events 3 • 6 months
|
|
Infections and infestations
Pharyngitis
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
General disorders
Noncardiac chest pain
|
6.2%
1/16 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.5%
2/16 • Number of events 2 • 6 months
|
Additional Information
Study Coordinator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-4760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place