Statin Therapy in Young Adult Survivors of Childhood Cancer
Condition: Cardiovascular Disease; Childhood ALL; Childhood NHL
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Cardiovascular Diseases
Intervention: Atorvastatin; Sugar Pill (Placebo)
Intervention description: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.; 6-Months of placebo (sugar) pill; oral, once daily
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Cardiovascular Disease; Childhood ALL; Childhood NHL

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Survivor of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkins's lymphoma
             (NHL) (treated for ALL or NHL before the age of 21 years old and ≥5 years
             post-treatment)

          -  18-39 years old

        Exclusion Criteria:

          -  Type 1 or 2 diabetes mellitus

          -  Prior treatment with hematopoietic stem cell transplant

          -  Low-density lipoprotein (LDL) -cholesterol ≥130 mg/dL (individuals with elevated
             LDL-cholesterol will be referred for clinical management of dyslipidemia)

          -  Alanine transaminase (ALT), Aspartate transaminase (AST), or Creatine kinase (CK)
             greater than 2 times the upper limit of normal

          -  Current or recent (within 6-months) use of lipid-lowering medication

          -  Recent initiation (within 6-months) of anti-hypertensive medication (individuals on
             stable therapy may be enrolled)

          -  Current or recent (within 6-months) use of fibric acid derivatives, lipid-modifying
             doses of niacin, cyclosporine or strong CYP3A4 inhibitors (i.e. clarithromycin, HIV
             protease inhibitors, and itraconazole)

          -  Pregnant, lactating or planning to become pregnant

          -  Liver/renal dysfunction