None listed
Conditions
Brief summary
The risk of cardiomyopathy as a side-effect is related to the total dose of anthracycline given to a patient. Cardiomyopathy may in turn cause symptoms of heart failure such as shortness of breath, increased tiredness, swelling of your ankles, inability to keep up your usual level of activity. These symptoms may be serious and even permanent. Current practice is to ensure normal heart function before starting anthracycline therapy. This is done using one of two available techniques: echocardiogram or gated cardiac blood pool scan (GCBPS). An echocardiogram uses ultrasound whereas a GCBPS uses a radioactive isotope. Use of a radioactive isotope means exposure to a small amount of radiation and a small risk of allergic reaction to the isotope. Current practice is to repeat one of these two tests only if the patient later experiences any symptoms of heart failure. The aim of this study is to assess whether a newer technique using Tissue Doppler Imaging (TDI) is more sensitive in detecting early changes in heart function. The study also examines whether changes in specific blood tests (known as cardiac biomarkers) correlate more closely to changes in heart function as measured by TDI or as measured by echocardiogram.. The use of TDI measurement as a technique is not proven in the monitoring of patients that receive anthracycline therapy and so is investigational in nature. For the purposes of this study heart function for all patients will be measured using echocardiogram and TDI. This will be done as one procedure.
Interventions
Biomarkers, electrocardiogram (ECG) and echocardiogram will be done at baseline (before chemotherapy), after cycle1, cycle 3 and 6 month post start day of chemotherapy. Cardiac biomarkers are study specific blood tests taken to assess and correlate changes in heart function with changes in heart function as measured by TDI or as measured by ejection fraction. An electrocardiogram (ECG) measures the electrical activity of the heart. The test takes about 10 minutes. Patients are usually given 4 to
Biomarkers, electrocardiogram (ECG) and echocardiogram will be done at baseline (before chemotherapy), after cycle1, cycle 3 and 6 month post start day of chemotherapy. Cardiac biomarkers are study specific blood tests taken to assess and correlate changes in heart function with changes in heart function as measured by TDI or as measured by ejection fraction. An electrocardiogram (ECG) measures the electrical activity of the heart. The test takes about 10 minutes. Patients are usually given 4 to 6 cycles of chemotherapy. One cyle lasts 3 weeks. Chemotherapy treatment may vary depending on patient's treatment plan. Some of tha drugs that may be administred are: Epirubuicn, 5-Fluorouracil, Cyclophosphamide, Taxotere.
Sponsors
Southern Health
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Histologically or cytologically proven invasive adenocarcinoma of the breast. 2.Early stage breast cancer T1-T4, any N Mo considered suitable for adjuvant chemotherapy. 3.Planned to receive at least 3 cycles of anthracycline based chemotherapy. 4.Age > 18 years. 5.Karnofsky Performance status index > 80%. 6.Routine laboratory requirements (within 28 days prior to registration): Haematology: - Neutrophils > 1.5 x 109/L - Platelets >100 x 109/L - Haemoglobin > 10 g/dL. Hepatic function: - Total bilirubin < 1 Upper Normal Limit (UNL) (patients with a well documented history of Gilbert’s Syndrome are eligible) - Aspartate transaminase (ASAT, SGOT) and AAlanine transaminase (ALAT, SGPT) < 2.5 UNL - Alkaline phosphatase < 5 UNL. Renal function: - Creatinine < 175 micro mol/L (2 mg/dL). 7.Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. 8.Written informed consent.
Exclusion criteria
1.Prior or concurrent systemic anticancer therapy for breast cancer (immunotherapy, hormone therapy, biological, or chemotherapy). 2.Prior or concurrent radiation therapy for breast cancer. 3.Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment. 4.M1 breast cancer. 5.Serious cardiac medical condition including but not limited to: Congestive Heart Failure; unstable angina pectoris; previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or high-risk uncontrolled arrhythmias. 6.Other serious illness or medical condition including but not limited to: active uncontrolled infection; active peptic ulcer; unstable diabetes mellitus; dementia or seizures that would prohibit the understanding of giving informed consent; 7.History of significant neurological or psychiatric disorders including psychotic disorders. 8.Current history of any neoplasm other than breast carcinoma. 9.Concurrent treatment with other experimental drugs. 10.Known allergy reactions or excipients used in the study. 11.Male patients.
Outcome results
None listed