PMRR-NO: Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00867477

Purpose

The goal of this clinical research study is to use a new breathing test that measures the amount of nitric oxide (NO) you exhale. Researchers want to compare your "NO" levels to the amount of inflammation in your lungs, as measured using a PET scan reading, and with respiratory symptoms questionnaire.

Condition	Intervention	Phase
Gastrointestinal Disease Esophageal Cancer Lung Cancer	Procedure: Breathing Test Behavioral: Respiratory Symptoms Questionnaire Procedure: Pet Scan	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Biomarker Study Comparing the Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide in Patients Who Receive Thoracic Radiotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Lung Cancer Nuclear Scans

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Comparison Patient's PMRR + Mean Exhaled NO Measurement [ Time Frame: Before starting radiation therapy (RT), after completing RT, and approximately 5 weeks later at completion of RT, and same day of restaging PET scan. ] [ Designated as safety issue: No ]
Association between exhaled nitric oxide (NO) and PMRR (pulmonary metabolic radiation response). FDG-PET imaging (to determine PMRR) and exhaled NO assessed three times on same day of PET imaging.

Estimated Enrollment:	150
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1: Esophagus Cancer Breathing Test + Respiratory Symptoms Questionnaire	Procedure: Breathing Test Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan). Behavioral: Respiratory Symptoms Questionnaire 3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests. Other Name: survey
Experimental: Cohort 2: Lung Cancer Breathing Test + Respiratory Symptoms Questionnaire	Procedure: Breathing Test Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan). Behavioral: Respiratory Symptoms Questionnaire 3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests. Other Name: survey Procedure: Pet Scan Between 40 and 50 days after the end of the radiation therapy. Ten (10) participants will receive a second PET scan within 2-7 days after the first PET scan in order to check reproducibility.

Arms

Assigned Interventions

Experimental: Cohort 1: Esophagus Cancer

Breathing Test + Respiratory Symptoms Questionnaire

Procedure: Breathing Test

Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).

Behavioral: Respiratory Symptoms Questionnaire

3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.

Other Name: survey

Experimental: Cohort 2: Lung Cancer

Breathing Test + Respiratory Symptoms Questionnaire

Procedure: Breathing Test

Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).

Behavioral: Respiratory Symptoms Questionnaire

3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.

Other Name: survey

Procedure: Pet Scan

Between 40 and 50 days after the end of the radiation therapy. Ten (10) participants will receive a second PET scan within 2-7 days after the first PET scan in order to check reproducibility.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with pathologic diagnosis of esophagus cancer.
For the cohort 2, patients with the pathological diagnosis of lung cancer.
For the cohort 3, patients with any pathological diagnosis of a thoracic malignancy.
Patients must sign informed consent.
Patients who will receive concurrent chemotherapy and radiation therapy will be undergoing PET-scan for restaging between 25 and 75 days after radio therapy.
For Lung Cohort, patients who will receive concurrent chemotherapy and radiation therapy or greater or equal to 3 weeks of radiation therapy alone.
For the Lung Cohort, participation in a PET-scan for restaging between 40-50 days after radiotherapy is required. 10 patients will receive a second PET-scan within 2-7 days as a test for reproducibility.

Exclusion Criteria:

Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
Patients who received thoracic radiotherapy prior to the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867477

Contacts

Contact: Thomas Guerrero, MD, PhD

713-563-2300

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Thomas Guerrero, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Thomas Guerrero, MD, PhD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00867477 History of Changes
Other Study ID Numbers:	2008-0632
Study First Received:	March 20, 2009
Last Updated:	March 29, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cancer of esophagus
Gastrointestine
esophagus cancer
Positron emission tomography
PET scan

Nitric oxide
NO
NO Breathing Test
Respiratory symptoms questionnaire

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Lung Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2012