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
I. To explore the adverse event profile of lisinopril, during and after external beam
radiation therapy (RT) to the lung.
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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Incidence of grade 3 or higher hypotension, acute kidney injury, allergic reaction, or anaphylaxis, as measured using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
Descriptive statistics of frequency (percentage) will be used to summarize adverse event (AE) incidence and severity in the lisinopril and placebo arms separately. Should incidence rates differ between the treatment arms, the Chi-square test may be utilized in an exploratory fashion to further characterize the differences. The difference between the two arms (point estimate and 95% confidence interval) will be reported.
Up to 3 months post-radiation therapy
Robert Miller, M.D.
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|Mayo Clinic Scottsdale-Phoenix||Scottsdale, Arizona 85259|