Clinical Trials Actively Recruiting Patients With Cardiotoxicity Resulting From Treatment


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The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with cardiotoxicity resulting from cancer or cancer treatment. These studies are investigating the effect of trastuzumab in survivors of breast cancer; the effects of radiation therapy on the heart; early diagnostic imaging of cancer-related cardiac injury; combination chemotherapies to minimize changes in left-ventricular function; and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

Observational

Study Title: Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors

Study Type: Observational

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer
Center

Purpose: To study whether strain and exercise testing can be used to detect late signs of heart damage from chemotherapy in patients with a history of HER2-positive breast cancer

Primary Outcome Measures: Cardiac function [time frame: 2 years]

Principal Investigator: Anthony Yu, MD, Memorial Sloan Kettering Cancer Center; (212) 639-7932

ClinicalTrials.gov Identifier: NCT02615054

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Study Title: Cardiotoxicity of Radiation Therapy

Study Type: Observational

Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania

Purpose: To determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart

Primary Outcome Measures: Number of Cardiovascular injury [time frame: 8 months]

Principal Investigator: Bonnie Ky, MD, Abramson Cancer Center of the University of Pennsylvania; (855) 216-0098, penncancertrials@emergingmed.com

ClinicalTrials.gov Identifier: NCT02769299

Phase I

Study Title: Early Imaging Detection of Cardiovascular Injury After Cancer

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: Comprehensive Cancer Center of Wake Forest University, National Cancer ­Institute

Purpose: To study how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving ­chemotherapy

Primary Outcome Measures: To correlate results of an automated MRI hardware/software platform for measuring left-ventricular function with manual results [time frame: up to 24 months]

Principal Investigator: William G. Hundley, MD, Comprehensive Cancer Center of Wake Forest University; (336) 716-6125, ghundley@wfubmc.edu

ClinicalTrials.gov Identifier: NCT01719562

Phase II

Study Title: A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Avera McKennan Hospital & University Health Center

Purpose: To determine whether coadministration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left-­ventricular ejection fraction

Primary Outcome Measures: Left-ventricular ejection fraction [time frame: 1 year]

Principal Investigator: Kirstin ­Williams, CNP, Avera McKennan Hospital & University Health Center; (605) 322-6900, kirstinwilliams@avera.org

ClinicalTrials.gov Identifier: NCT02472353

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Study Title: Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center

Purpose: To determine whether taking simvastatin while receiving doxorubicin for the treatment of breast cancer will minimize damage to the heart

Primary Outcome Measures: Change in echocardiographic global longitudinal strain [time frame: 10–15 weeks]

Principal Investigator: Karen Smith, MD, MPH, SKCCC at Johns Hopkins; (202) 660-6500, ksmith60@jhmi@edu

ClinicalTrials.gov Identifier: NCT02096588

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Study Title: Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Cedars-Sinai Medical Center, California Breast Cancer Research Program

Purpose: To examine the effects of atorvastatin on changes to the heart among women undergoing breast cancer treatment

Primary Outcome Measures: Change in global circumferential strain measured by cardiac MRI [time frame: baseline to 12 months post-intervention initiation]

Principal Investigator: Marc Goodman, PhD, Cedars-Sinai Medical Center; contact Jaime Richardson (310) 423-2133, clinical.trial.info@cshs.org or Jenny Lester (310) 423-6241, jenny.lester@cshs.org

ClinicalTrials.gov Identifier: NCT02674204

Phase III

Study Title: Pragmatic Randomized Trial of Proton vs Photon Therapy for Patients With Nonmetastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Study Type: Interventional/parallel assignment

Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania, Patient-Centered Outcomes Research Institute

Purpose: A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes

Primary Outcome Measures: Effectiveness of proton therapy vs photon therapy [time frame: 10 years]: Compare the effectiveness of proton vs photon therapy in reducing major cardiovascular events, defined as atherosclerotic coronary heart disease or other heart disease death; myocardial infarction; coronary revascularization; or hospitalization for a major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina)

Principal Investigator: Justin Bekelman, MD, Abramson Cancer Center of the University of Pennsylvania; (215) 662-7266, bekelman@uphs.upenn.edu

ClinicalTrials.gov Identifier: NCT02603341 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.

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