Dyspnea, Lung Cancer, Pulmonary Complications, Radiation Fibrosis
Conditions
Keywords
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
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.
Interventions
DRUGLosartan
50 mg Losartan will be taken daily by subjects for 24 weeks
Sponsors
National Cancer Institute (NCI)
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in carbon monoxide diffusing capacity (DLCO) at 6 months | 6 months |
Secondary
| Measure | 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 |
Outcome results
None listed