Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00880386|
Recruitment Status : Withdrawn (Study concept was not approved by NCI. Study was never activated. No enrollment)
First Posted : April 13, 2009
Last Update Posted : May 2, 2017
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 or disease||Intervention/treatment||Phase|
|Dyspnea Lung Cancer Pulmonary Complications Radiation Fibrosis||Drug: Losartan||Not Applicable|
- To evaluate the effects of losartan potassium on the disease progression in patients with stage I-III non-small cell lung cancer and radiation-induced pulmonary fibrosis.
- To determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis.
- The evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (FEV_1 and FVC) in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||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|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Losartan Group
50 mg Losartan tablet taken daily for 24 weeks
50 mg Losartan will be taken daily by subjects for 24 weeks
- Change in carbon monoxide diffusing capacity (DLCO) at 6 months [ Time Frame: 6 months ]
- Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis [ Time Frame: 6 months ]
- Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880386
|Principal Investigator:||Marisa Couluris, DO||University of South Florida|