Clinical trial · Interventional
Statin Therapy in Young Adult Survivors of Childhood Cancer
Pilot Study of Statin Therapy in Young Adult Survivors of Childhood Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Disease | — | UNRESOLVED | — |
| Childhood ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Childhood NHL | Childhood Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Sugar Pill (Placebo) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Atorvastatin
- description
- 6-Months Atorvastatin Therapy; 40mg oral, once daily
- interventionNames
- Drug: Atorvastatin
- type
- PLACEBO_COMPARATOR
- label
- Sugar Pill (Placebo)
- description
- 6-Months Placebo (sugar pill); oral, once daily
- interventionNames
- Drug: Sugar Pill (Placebo)
Primary outcomes (1)
- measure
- Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months
- timeFrame
- Baseline and 6-Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMarlatt KL, Steinberger J, Rudser KD, Dengel DR, Sadak KT, Lee JL, Blaes AH, Duprez DA, Perkins JL, Ross JA, Kelly AS. The Effect of Atorvastatin on Vascular Function and Structure in Young Adult Survivors of Childhood Cancer: A Randomized, Placebo-Controlled Pilot Clinical Trial. J Adolesc Young Adult Oncol. 2019 Aug;8(4):442-450. doi: 10.1089/jayao.2017.0075. Epub 2017 Aug 30. PMID 28853979