Phase 2 N=27 Randomized Quadruple-blind Treatment

Statin Therapy in Young Adult Survivors of Childhood Cancer

Cardiovascular Disease · Childhood ALL · Childhood NHL

Bottom Line

View on ClinicalTrials.gov: NCT01733953 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcome: Primary: Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months — -0.5; -3.4 percentage change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Atorvastatin (Drug); Sugar Pill (Placebo) (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months	-0.5; -3.4	—
SECONDARY Change From Baseline in Carotid Artery Compliance at 6-Months	-.34; 0.57	—
SECONDARY Change From Baseline in Carotid Artery Distensibility at 6-Months	0.31; 0.33	—
SECONDARY Change From Baseline in Pulse Wave Velocity at 6-Months	-0.52; -0.3	—
SECONDARY Change From Baseline in Augmentation Index at 6-Months	-0.66; -6.01	—
SECONDARY Change From Baseline in Carotid Intima-Media Thickness at 6-Months	-.01; 0.01	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01733953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.