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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00880386 |
RATIONALE: Losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage I, stage II, or stage III non-small cell lung cancer.
Condition | Intervention |
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Dyspnea Lung Cancer Pulmonary Complications Radiation Fibrosis |
Drug: losartan potassium Other: questionnaire administration Procedure: breath test |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity.
Patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the Visual Analog Scale (VAS) at baseline and at weeks 12 and 24.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
Diagnosis of radiation therapy-induced pulmonary fibrosis within 2 years of last radiation treatment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Responsible Party: | H. Lee Moffitt Cancer Center CCOP Research Base ( Viki Huegel ) |
Study ID Numbers: | CDR0000637808, MCC-PILOT-0208 |
Study First Received: | April 10, 2009 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00880386 History of Changes |
Health Authority: | Unspecified |
dyspnea stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer |
stage IIIB non-small cell lung cancer pulmonary complications radiation fibrosis |
Thoracic Neoplasms Fibrosis Disorders of Environmental Origin Pulmonary Fibrosis Signs and Symptoms Respiratory Tract Diseases Lung Neoplasms Signs and Symptoms, Respiratory Anti-Arrhythmia Agents Dyspnea Lung Diseases, Interstitial Losartan Respiration Disorders |
Wounds and Injuries Cardiovascular Agents Angiotensin II Antihypertensive Agents Carcinoma Angiotensin II Type 1 Receptor Blockers Lung Diseases Non-small Cell Lung Cancer Radiation Pneumonitis Carcinoma, Non-Small-Cell Lung Pneumonia Radiation Injuries Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Fibrosis Disorders of Environmental Origin Pulmonary Fibrosis Signs and Symptoms Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Signs and Symptoms, Respiratory Anti-Arrhythmia Agents Dyspnea Respiratory Tract Neoplasms |
Lung Diseases, Interstitial Losartan Neoplasms by Histologic Type Respiration Disorders Wounds and Injuries Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Carcinoma Angiotensin II Type 1 Receptor Blockers Neoplasms Lung Diseases Radiation Pneumonitis Carcinoma, Non-Small-Cell Lung Radiation Injuries |