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

Not Applicable

Withdrawn

• Conditions: Pulmonary Complications; Radiation Fibrosis; Dyspnea; Lung Cancer
• Interventions: Drug: Losartan

• Registration Number: NCT00880386
• Lead Sponsor: University of South Florida

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Losartan Group	Losartan	50 mg Losartan tablet taken daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change in carbon monoxide diffusing capacity (DLCO) at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Pulmonary function measurements of FEV1 and FVC and dyspnea score at 6 months	6 months
Feasibility of losartan potassium as treatment for radiation-induced pulmonary fibrosis	6 months