Strain Echocardiography to Predict Cardiotoxicity in Patients Receiving Chemotherapy Containing Doxorubicin

NCT02423356 | Completed DMC

• 1 other identifier: IUCRO-0483
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate the heart functioning of patients being treated with with doxorubicin chemotherapy who have sarcoma, lymphoma or breast cancer in order to better predict risk of developing symptomatic heart failure.

Conditions

Breast Neoplasms; Lymphoma; Sarcoma

Keywords

breast cancer; sarcoma; lymphoma; echocardiography; cardiotoxicity; pharmacogenetics; doxorubicin; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Composite cardiotoxicity

  Transthoracic echocardiograms with strain imaging

  Up to 28 days prior to beginning chemotherapy, during chemotherapy (specifically, at the visit that will administer doxorubicin to a cumulative total of at least 225mg/m2), 6 months after starting chemotherapy, and 12 months after starting chemotherapy

Secondary Outcomes (1)

• Serum cardiac biomarkers as predictors of composite cardiotoxicity

  Up to 28 days prior to beginning chemotherapy, during chemotherapy (specifically, at the visit that will administer doxorubicin to a cumulative total of at least 225mg/m2), 6 months after starting chemotherapy, and 12 months after starting chemotherapy

Other Outcomes (1)

• Pharmacogenomic biomarkers as predictors of composite cardiotoxicity (exploratory)

  During chemotherapy (up to 12 months)

Study Arms (1)

Echocardiography

All patients will receive 4 echocardiograms and 4 blood draws. The blood draws and echocardiograms will occur at the same visits.

Procedure: Echocardiogram

Interventions

Echocardiogram PROCEDURE

An echocardiogram uses sound waves to produce images of the heart. This commonly used test allows doctors to see how your the heart is beating and pumping blood. Doctors can use the images from an echocardiogram to identify various abnormalities in the heart muscle and valves.

Also known as: Transthoracic complete, strain imaging, 3D volumes, Transthoracic limited, strain imaging

Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2(-) breast cancer, sarcoma, and lymphoma patients receiving doxorubicin chemotherapy as part of standard protocols

You may qualify if:

• Patients must be at least 18 years old at the time of informed consent
• Patients must be able to speak and read English.
• Patients must be able to provide written informed consent and HIPAA authorization
• Patients must have a current diagnosis of sarcoma, lymphoma, or HER2(-) breast cancer
• Patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease.
• Patients must have planned treatment with doxorubicin:
• Patients with sarcoma must have an initial planned regimen including 75 mg/m2 doxorubicin for at least 4 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
• Patients with lymphoma must have an initial planned regimen including 50 mg/m2of doxorubicin for at least 6 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
• Patients with breast cancer must have an initial planned regimen including 60 mg/m2 of doxorubicin for at least 4 cycles. Breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled.
• NOTE: Patients can be on additional chemotherapeutic agents.
• Patients must have their echocardiograms performed such that strain may be calculated using either GE or Tomtec software.

You may not qualify if:

• Clinical history of heart failure or ejection fraction (EF) on initial exam is \<53%.
• Initial echocardiograms are not interpretable.
• Wall motion abnormalities are present on initial echocardiograms.
• Strain on initial echocardiograms cannot be calculated.

Sponsors & Collaborators

• Daniel Rushing: lead

Study Sites (2)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphoma; Sarcoma; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Daniel A. Rushing, MD

  Indiana University (IU) School of Medicine, Department of Medicine; IU Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 22, 2015
• Study Start: April 23, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

US (2)