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Brief Title: Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer
Official Title: A Double-Blind Pilot Study to Measure the Effect of Lisinopril vs. Placebo on Pulmonary Distress in Patients Receiving External Beam Radiotherapy to the Lung
Study ID: NCT01880528
Brief Summary: This pilot clinical trial studies lisinopril in reducing shortness of breath caused by radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects caused by radiation therapy in patients with lung cancer.
Detailed Description: PRIMARY OBJECTIVES: I. To explore the adverse event profile of lisinopril, during and after external beam radiation therapy (RT) to the lung. SECONDARY OBJECTIVES: I. To explore the level of patient-reported acute respiratory distress (dyspnea) during and after external beam RT. II. To explore the level of patient-reported symptoms during and after external beam RT. III. To explore the impact of lisinopril treatment on patient quality of life (QOL) during and after external beam RT. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Beginning within 7 days of beginning radiation therapy, patients receive lisinopril orally (PO) once daily (QD) on days 1-7. ARM II: Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD on days 1-7. In both arms, treatment repeats every 7 days for until 3 months after completion of radiation therapy in the absence of disease progression or unacceptable toxicity.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Mayo Clinic, Rochester, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Name: Robert Miller, M.D.
Affiliation: Mayo Clinic
Role: STUDY_CHAIR