Statin Therapy in Young Adult Survivors of Childhood Cancer

NCT01733953 | Completed Phase 2 Results DMC

• 1 other identifier: 1207M17202
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease; Childhood ALL; Childhood NHL

Keywords

Cardiovascular Disease; Childhood ALL; Childhood NHL

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months

  Baseline and 6-Months

Secondary Outcomes (5)

• Change From Baseline in Carotid Artery Compliance at 6-Months

  Baseline and 6-Months

• Change From Baseline in Carotid Artery Distensibility at 6-Months

  Baseline and 6-Months

• Change From Baseline in Pulse Wave Velocity at 6-Months

  Baseline and 6-Months

• Change From Baseline in Augmentation Index at 6-Months

  Baseline and 6-Months

• Change From Baseline in Carotid Intima-Media Thickness at 6-Months

  Baseline and 6-Months

Study Arms (2)

Atorvastatin

EXPERIMENTAL

6-Months Atorvastatin Therapy; 40mg oral, once daily

Drug: Atorvastatin

Sugar Pill (Placebo)

PLACEBO COMPARATOR

6-Months Placebo (sugar pill); oral, once daily

Drug: Sugar Pill (Placebo)

Interventions

Atorvastatin DRUG

6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.

Also known as: Lipitor

Atorvastatin

Sugar Pill (Placebo) DRUG

6-Months of placebo (sugar) pill; oral, once daily

Also known as: Placebo

Sugar Pill (Placebo)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Marlatt 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 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Atorvastatin; Sugars

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Carbohydrates

Results Point of Contact

• Title: Cameron Naughton
• Organization: University of Minnesota

naug0009@umn.edu

612-625-3623

Study Officials

• Aaron S Kelly, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 14, 2016
• Results First Posted: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)