At a glance
ClinicalIndex Comparison Record- ✓Survivor of childhood ALL or NHL treated before age 21 and at least 5 years post-treatment
- ✓Age 18–39 years
- ✕Type 1 or 2 diabetes mellitus
- ✕Prior hematopoietic stem cell transplant
- ✕LDL-cholesterol ≥130 mg/dL
- ✕ALT, AST, or CK greater than 2× upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study of Statin Therapy in Young Adult Survivors of Childhood Cancer
In Brief
A Phase 2 clinical trial evaluating Atorvastatin and Sugar Pill (Placebo) for Cardiovascular Disease and 2 related conditions. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.
6-Months of placebo (sugar) pill; oral, once daily