Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors

Stopped early · Not applicable

Conditions studied: Carotid Artery Disease

In brief

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.

Key facts

Study ID

NCT00746603

Run by

Columbia University

People needed

3

Starts

2008-01-01

Expected to finish

2009-07-01

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least three years from completion of treatment for Hodgkin's Disease
• Age 18- 35
• Ability to complete self report questionnaires in either English or Spanish
• Willingness of patient, or parent/guardian if patient less than 18 years of age to sign consent to participate in study
• Willingness of patient to sign assent if greater than 7 years of age and less than 18 years

You may not qualify if…

• Pregnant or breast feeding
• Tanner Stage 1
• Currently taking cyclosporine, niacin, antiretrovirals, macrolide antibiotic, azole antifungal
• Liver enzymes greater than 1.5 times the upper level of normal
• Creatine Kinase greater than 2 times the upper level of normal
• Use of estrogen containing contraceptive

Where it is running

• Columbia Univeristy Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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