Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
NCT ID: NCT01988571
Last Updated: 2022-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
279 participants
INTERVENTIONAL
2014-02-01
2020-09-24
Brief Summary
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Detailed Description
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Specific Aim 1:
To determine if Atorvastatin(Lipitor) administration preserves left ventricular ejection fraction (LVEF) 24 months after initiation of Anthracycline-based adjuvant therapy for adjuvant treatment of breast cancer or lymphoma.
Specific Aim 2:
To determine if baseline to 6-month differences in LVEF predict baseline to 24-month differences in LVEF after Anthracycline-based adjuvant therapy and concomitant atorvastatin therapy.
To achieve these aims, we will perform a double-blind, placebo-controlled, randomized clinical trial of 0 or 40 mg of atorvastatin/day in 278 individuals scheduled to receive Anthracycline-based chemotherapy for treatment of Stage I-III breast cancer or lymphoma Stage I-IV with a projected \> 2 year life expectancy. We will use innovative noninvasive magnetic resonance imaging (MRI) procedures to accurately measure LVEF. In addition, we will measure left ventricle (LV) volumes, myocardial strain, fibrosis, aortic pulse wave velocity (PWV) and wall thickness, all factors that can influence LVEF by altering LV pre-load, after-load, and contractility.19,20 Advanced serum biomarkers will be measured that assess for the presence of oxidative/nitrosative stress, systemic inflammation and circulating neurohormones that also may influence LVEF.
This study will test a new clinical paradigm to manage breast cancer: primary prevention of Anthracycline-based adjuvant therapy-related LV dysfunction using pre-treatment with low-cost statins. In addition, this trial will be the first systematic collection of data regarding the mechanism(s) and time course by which LV dysfunction and subsequent chronic heart failure (CHF) evolve in individuals given Anthracycline-based chemotherapy for breast cancer or lymphoma. These data will be useful to physicians trying to determine the optimal cardiac protection strategies when administering adjuvant chemotherapeutic regimens to their breast cancer or lymphoma patients. The objective of this research is to use inexpensive medications to preserve cardiovascular (CV) health and thereby improve overall survival in the growing number of breast cancer and lymphoma patients.
SECONDARY OBJECTIVES
Specific Aim 1:
To document the effect of Atorvastatin (Lipitor) on cognitive function using a battery of neurocognitive tests (HVLT, Rey-osterrieth Figure, controlled oral word association test (COWA), Trail-making Parts A and B, Digit Span and Grooved Pegboard) in breast cancer and lymphoma patients receiving an anthracycline.
Specific Aim 2:
To document the effect of Atorvastatin(Lipitor) on self-reported quality of life using validated questionnaires (PROMIS including: General form, Cog Concerns, Cog Abilities, Fatigue, Pain intensity and interference, Sleep Disturbance, Physical Functioning and Social Functioning) in breast cancer and lymphoma patients receiving an anthracycline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm 1 - Atorvastatin
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin
40 mg tablet taken by mouth each morning for 24 months.
Arm 2 - Placebo
One placebo tablet each morning by mouth for 24 months.
Atorvastatin
40 mg tablet taken by mouth each morning for 24 months.
Placebo
One placebo tablet taken each morning orally for 24 months.
Interventions
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Atorvastatin
40 mg tablet taken by mouth each morning for 24 months.
Placebo
One placebo tablet taken each morning orally for 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to receive adjuvant chemotherapy with an Anthracycline (doxorubicin and epirubicin)
* 21 years of age or older
* LVEF \> 50% (Most recent within the last 5 years)
* Prior administration of anthracyclines is acceptable if therapy was completed \> 6 months prior to study enrollment
* Patients that are receiving or have received chemotherapy regimens are allowed
* Able to hold breath for 10 seconds
* Prior cancers allowed if no evidence of disease in last 5 years
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
* Current postmenopausal hormone-replacement therapy
* Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
* Scheduled to receive neoadjuvant chemotherapy with an anthracycline
* No active liver disease allowed
* Uncontrolled hypothyroidism
* Recent history (within past 3 years) of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, use of immunosuppressant agents, or another medical condition that might compromise safety or the successful completion of the study.
* Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal;pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
* Unstable angina; significant ventricular arrhythmias (\>20 premature ventricular complexes (PVCs)/min due to gating difficulty) atrial fibrillation with uncontrolled ventricular response; coronary artery disease; acute myocardial infarction within 28 days
* Current use of Cytochrome P450 (CYP3A4) inhibitors. These include Clarithromycin, HIV protease inhibitors, Itraconazole, grapefruit juice, Cyclosporine, Rifampin or Digoxin
* Current or history of hepatic dysfunction
* Unable to provide informed consent
* Claustrophobia
* Planning to move within 24 months of trial enrollment
* Pregnant or breast-feeding
21 Years
100 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Gregory Hundley, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Mission Hospital
Asheville, North Carolina, United States
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, United States
Southern Oncology Specialists-Huntersville
Huntersville, North Carolina, United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, United States
Novant Health Cancer Specialists-Matthews
Matthews, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Shenandoah Oncology PC
Winchester, Virginia, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Countries
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References
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Grizzard PJ, O'Connell NS, Rapp SR, Olson KC, Bellissimo MP, Hughes AN, Ladd AC, Weaver KE, Wagner LI, Ruddy KJ, Ky B, D'Agostino RB, Hundley WG. Preserved Cognitive Function After Statin Administration During Cancer Treatment With Doxorubicin: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538325. doi: 10.1001/jamanetworkopen.2025.38325.
Sutton AL, O'Connell NS, Lucas AR, Olson KC, Reding KW, Sheppard VB, Ky B, Ruddy KJ, Weaver KE, Hundley WG. Socioeconomic status and left ventricular ejection fraction decline in breast cancer survivors following receipt of doxorubicin (PREVENT WF-98213). Cardiooncology. 2025 Feb 5;11(1):11. doi: 10.1186/s40959-025-00311-y.
Hundley WG, D'Agostino R Jr, Crotts T, Craver K, Hackney MH, Jordan JH, Ky B, Wagner LI, Herrington DM, Yeboah J, Reding KW, Ladd AC, Rapp SR, Russo S, O'Connell N, Weaver KE, Dressler EV, Ge Y, Melin SA, Gudena V, Lesser GJ. Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment. NEJM Evid. 2022 Sep;1(9):10.1056/evidoa2200097. doi: 10.1056/evidoa2200097. Epub 2022 Aug 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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REBACCCWFU 98213
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2013-01760
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB00038639
Identifier Type: -
Identifier Source: org_study_id
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