Statin Therapy in Young Adult Survivors of Childhood Cancer
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Adult survivors of childhood cancer are at high risk of developing cardiovascular disease.
Therapies used to treat many cancers, such as chemotherapy and radiation, likely cause damage
to the surface of the artery wall called the endothelial layer, leading to the induction of
atherosclerosis and eventual cardiovascular disease. HMG coenzyme A reductase inhibitors, or
statins, improve endothelial function independent of cholesterol-lowering. In addition,
statins have been shown to reduce arterial stiffness and slow arterial thickening. Despite
strong evidence supporting the vascular benefits of statins in many different patient
populations, these medications have never been studied in cancer survivors. Therefore, the
overall objective of this study is to evaluate the effects of statin therapy on vascular
health in young adult survivors of childhood cancer.
Twenty-four young adult (age 18-39 years old) survivors of childhood acute lymphoblastic
leukemia (ALL) or non-Hodgkin's lymphoma (NHL) will be enrolled in a six-month randomized,
double-blind (participants and investigators), placebo-controlled pilot clinical trial
comparing the effects of atorvastatin versus placebo on endothelial function and other
measures of vascular health.
Our primary objective is to evaluate the effects of 6-months of statin therapy on conduit
artery endothelial function in young adult survivors of childhood cancer. The investigators
hypothesize that, compared to placebo, atorvastatin will significantly increase brachial
artery flow-mediated dilation in survivors of childhood acute lymphoblastic leukemia and
non-Hodgkin's lymphoma.
Phase:
Phase 2
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute