Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation

Lung Cancer Clinical Trial

Official title:

Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182155
• Other study ID #: LUN0043
• Secondary ID: SU-08102010-6705
• Status: Completed
• Phase: N/A
• First received: August 12, 2010
• Last updated: June 30, 2016
• Start date: August 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Patients treated with radiation therapy for lung tumors can experience inflammation after treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in the composition of exhaled breath in patients undergoing radiotherapy. If changes can be detected, this may ultimately serve as biomarkers for identifying patients at highest risk for radiation-induced lung injury (radiation pneumonitis).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of any type of lung tumor

• Medical recommendation (independent of the study) that the patient undergo thoracic radiation therapy. Radiation therapy may be either fractionated or hypofractionated (i.e. radiosurgery)

• Age >= 18 years old

• Any gender and any ethnic background will be recruited

• Capable of giving written informed consent

Exclusion Criteria:

• Inability of giving written informed consent

• Pregnancy or breast-feeding

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Procedure:
• Exhaled Breath Sampling
Standard of care

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements		Every 3 months for 1 year	No
Secondary	Pre and post-radiation CO (carbon monoxide), CO2 (carbon dioxide), and N2O (nitrous oxide) measurements and feasibility as the fraction of patients unable to give a breath sample. Adverse events are not expected but any that appear related to the breath		1 yr	No