Losartan in Treating Pulmonary Fibrosis in Patients With Stage I, II, or III Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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A Pilot Project to Determine the Effect of Losartan (Cozaar) on Radiation-Induced Pulmonary Fibrosis in Patients With Non-Small Cell Lung Cancer

Conditions
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Dyspnea, Lung Cancer, Pulmonary Complications, Radiation Fibrosis

Intervention / Treatment
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* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: At least 18 years of age or older Diagnosed with non-small cell lung cancer stage I, II, IIIa, or IIIb Diagnosis of radiation-induced pulmonary fibrosis (as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] V3.0 Grade I to Grade III) and within 2 years of the last radiation therapy treatment EXCLUSION CRITERIA: Patients with a pneumonectomy Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker Use of an angiotensin II receptor blocker currently or within 6 months of study entry which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, and telmisartan Bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled hypotension Patients taking lithium Currently smoking or smoked within 6 months of study entry Pregnant, intending to become pregnant or breastfeeding Baseline systolic blood pressure < 100 mmHg History of lung transplant History of kidney failure or liver disease Inability to attend clinic visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan Group<br>50 mg Losartan tablet taken daily for 24 weeks | Drug: Losartan<br>* 50 mg Losartan will be taken daily by subjects for 24 weeks<br>* Other names: losartan potassium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in carbon monoxide diffusing capacity (DLCO) at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis |  | 6 months | 
| Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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