Clinical trial · Observational
Strain Echocardiography to Predict Cardiotoxicity in Patients Receiving Chemotherapy Containing Doxorubicin
The Ability of Strain Echocardiography to Predict Cardiotoxicity in Patients Receiving Standard Chemotherapy Regimens Containing Doxorubicin
NCT02423356CI-TRIAL-00034478completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Echocardiogram | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Echocardiography
- description
- All patients will receive 4 echocardiograms and 4 blood draws. The blood draws and echocardiograms will occur at the same visits.
- interventionNames
- Procedure: Echocardiogram
Primary outcomes (1)
- measure
- Composite cardiotoxicity
- timeFrame
- 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
- description
- Transthoracic echocardiograms with strain imaging
Secondary outcomes (1)
- measure
- Serum cardiac biomarkers as predictors of composite cardiotoxicity
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be at least 18 years old at the time of informed consent 2. Patients must be able to speak and read English. 3. Patients must be able to provide written informed consent and HIPAA authorization 4. Patients must have a current diagnosis of sarcoma, lymphoma, or HER2(-) breast cancer 5. Patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease. 6. 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. 7. Patients must have their echocardiograms performed such that strain may be calculated using either GE or Tomtec software. Exclusion Criteria: 1. Clinical history of heart failure or ejection fraction (EF) on initial exam is \<53%. 2. Initial echocardiograms are not interpretable. 3. Wall motion abnormalities are present on initial echocardiograms. 4. Strain on initial echocardiograms cannot be calculated.
References
Publications (0)
Data not yet available
No reference posted for this study.