Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
Status:
Terminated
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm
survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus,
the emphasis for future therapeutic interventions must include attention to the late effects
of therapy. The development of cardiovascular disease as a late effect of radiation therapy
has been well described and documented. Our recent pilot study of child and young adult HD
survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid
Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were
positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic
BP. This finding was present in children and young adults who had received no or low dose
radiation suggesting that chemotherapy or the disease process itself contributes to the
development of atherosclerosis and risk for cardiovascular disease. Numerous studies have
shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of
atherosclerosis in adults. These agents have been studied in children and young adults for
over a decade.
The primary aim of this study is:
To obtain pilot safety data on the use of simvastatin in young adults treated for HD.
The secondary aims of this study are:
To obtain pilot data on the effect of simvastatin on subclinical carotid artery
atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.
To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the
serum of young adults treated for HD.
To obtain pilot data to serve as the basis for the development of a multicenter randomized
study for the use of simvastatin in survivors of HD.