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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01182155
First received: August 12, 2010
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention
Lung Cancer
Non-Small Cell Lung Cancer
Small Cell Lung Cancer
 Procedure: Exhaled Breath Sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation: A Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements [ Time Frame: Every 3 months for 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Exhaled Breath Sampling
    Standard of care
    Other Name: breath gas analysis
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with lung tumors who are undergoing radiation therapy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182155

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Maximilian Diehn MD/PhD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01182155     History of Changes
Other Study ID Numbers: LUN0043, SU-08102010-6705
Study First Received: August 12, 2010
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Lung Cancer Non-Small Cell Cancer (NSCLC)
Lung Cancer Small Cell Lung Cancer (SCLC)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013