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

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).

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exhaled Breath Sampling

Procedure

Standard of care

Other names: breath gas analysis

Primary outcomes

Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements

Time frame: Every 3 months for 1 year

Secondary outcomes

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

Time frame: 1 yr

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Aug 16, 2010
Registry last updated: Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed