A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
A Intervention Arm
Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma
干预措施: Simvastatin (Drug)
结局指标
主要结局
Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity
时间窗: Up to 26 weeks
Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.
Number of Participants Experiencing Grade 3 or Higher Liver Toxicity
时间窗: Up to 26 Weeks
Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.
Change in Carotid Intima-media Thickness Test (CIMT)
时间窗: Up to 26 Weeks
A change in CIMT measurements ( measured in millimeters (mm)) will be performed.
次要结局
未报告次要终点