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Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00806507 |
The primary objectives of this study are:
Condition | Intervention |
---|---|
Breast Cancer |
Procedure: Echocardiograms Procedure: Blood Test |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients |
Estimated Enrollment: | 20 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
Echocardiogram + Blood Test
|
Procedure: Echocardiograms
Additional views performed in 5-10 minutes of regularly scheduled echocardiograms.
Procedure: Blood Test
Measuring of hormones and metabolic proteins (such as sugars and acids).
|
Echocardiogram:
Because of the heart-related side effects of chemotherapy and trastuzumab, your regular doctor will monitor your heart's function as part of your routine care. You will have echocardiograms performed before you begin treatment, and then every 3 months. An echocardiogram uses sound waves to check your heart's health.
If you decide to take part in this study, researchers will take several additional pictures of your heart during each of your regularly scheduled echocardiograms. The additional pictures will make the procedure take about 5-10 minutes longer than the regular echocardiogram. These pictures will be viewed in a different way than the standard echocardiogram pictures. Researchers hope viewing the pictures this way can help researchers to find heart problems earlier than the usual tests.
Blood Tests:
Blood (about 4 teaspoon each time) will be drawn during the routine blood draw that occurs closest to the regularly scheduled echocardiograms.
The heart produces hormones called BNP and NT-proBNP. These hormones can be measured in the blood. BNP and NT-proBNP levels can be higher when the heart is not working as well. Researchers will measure these hormones at the time of each echocardiogram. Researchers hope to learn whether measuring these hormones can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Researchers will also measure metabolic proteins (such as sugars and acids) in the blood. Researchers hope to learn whether measuring these metabolic proteins can help identify the heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
Because protein, sugar or acid levels may be temporarily changed after you eat, you will be asked not to eat overnight before having your blood drawn.
Study Visits:
You will have 6 study visits around the time that you have an echocardiogram. These visits will occur before you take Herceptin, when you begin Herceptin, and 3, 6, 9, and 12 months later. These study visits will be scheduled on days when you are already making a visit to your regular doctor.
You will not have to make any special visits to the hospital for this research study.
During each study visit, you will be asked about any symptoms you may be experiencing, and any medications you may be taking. Your blood pressure and heart rate will be measured.
Length of Study:
You will be considered off-study once you complete the 6 study visits.
THIS IS AN INVESTIGATIONAL STUDY. Up to 100 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Breast cancer patients treated with chemotherapy and Herceptin (trastuzumab)
Inclusion Criteria:
Exclusion Criteria:
Contact: Juan C Plana, MD | 713-794-4197 |
United States, Massachusetts | |
Partners Healthcare Systems | Recruiting |
Boston, Massachusetts, United States, 02199 |
Principal Investigator: | Juan C Plana, MD | M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Juan C. Plana, MD/Assistant Professor ) |
Study ID Numbers: | 2007-0339 |
Study First Received: | November 20, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00806507 History of Changes |
Health Authority: | United States: Institutional Review Board |
Tissue Doppler Imaging B-type natriuretic peptide Advia Centaur immunoassay system GE Vivid ultrasound machine |
Roche 2010 system Echocardiography Herceptin |
Natriuretic Peptide, Brain Skin Diseases Trastuzumab |
Breast Neoplasms Hormones Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |