Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)
Investigating the Effects of Chemotherapy on Heart Health in Breast Cancer Patients
Brief description of study.
This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy,Breast Cancer
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Age: 18 years - 100 years
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Gender: Female
Inclusion Criteria
Inclusion Criteria for Women with Stage I - III Breast Cancer:
-Stage I-III female breast cancer (including inflammatory and newly diagnosed or locally recurrent breast cancer) but not metastatic breast cancer being treated with curative intent
-Scheduled to receive chemotherapy
- Able to hold breath for 10 seconds
- Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
- Able to exercise on a treadmill or stationary cycle
- Participants in other ongoing clinical trials are eligible for this study
Inclusion Criteria for Women Free of Cancer for Comparison:
- Healthy female without known coronary artery disease
- Able to hold breath 10 seconds
- Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
- Able to exercise on a treadmill or stationary cycle
- No hx. of cancer
- Never received chemotherapy, radiation therapy, immunotherapy, or had breast surgery
Exclusion Criteria
Exclusion Criteria for Women with Stage I-III Breast Cancer:
- Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
- Symptomatic claustrophobia
- At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled.
- Severe pulmonary hypertension
- Within the past 6 months:
-- Acute pulmonary embolus
-- Deep vein thrombosis
- Within the past month:
-- Heart attack
-- Unstable or stable angina (cardiac chest pain)
-- Left main coronary artery disease
-- Symptomatic heart failure
-- Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 100mm Hg)
-- Severe valvular heart disease
-- Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
-- Aortic aneurism (>45 mm diameter) or aortic dissection
-- Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
-- Hypertrophic obstructive cardiomyopathy
Exclusion Criteria for Women Free of Cancer for Comparison:
- Inflammatory conditions such as lupus or inflammatory bowel disease
- Overt coronary artery disease or heart failure
- Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
- Symptomatic claustrophobia
- At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled.
- Severe pulmonary hypertension
- Within the past 6 months:
-- Acute pulmonary embolus
-- Deep vein thrombosis
- Within the past month:
-- Heart attack
-- Unstable or stable angina (cardiac chest pain)
-- Left main coronary artery disease
-- Symptomatic heart failure
-- Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 100mm Hg)
-- Severe valvular heart disease
-- Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
-- Aortic aneurism (>45 mm diameter) or aortic dissection
-- Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
-- Hypertrophic obstructive cardiomyopathy
This study investigates how chemotherapy affects the heart, exercise ability, and fatigue in women with breast cancer compared to women without cancer. Breast cancer is a disease where cells in the breast grow out of control. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The study aims to understand if these treatments have specific effects on the heart and physical activity levels.
Participants will undergo various procedures to assess their heart health and ability to exercise. This may include tests like treadmill or stationary cycle exercises, where participants' heart rates and physical responses are monitored. The study will compare results between those receiving chemotherapy and those who are cancer-free.
- Who can participate: Women with Stage I-III breast cancer scheduled for chemotherapy can participate. Healthy women without cancer can also join for comparison. Participants must be able to walk two blocks and exercise on a treadmill or stationary cycle.
- Study details: Participants will be involved in exercises and health assessments to monitor heart and physical activity responses. The study includes a comparison between those receiving chemotherapy and healthy individuals. A placebo is not used in this study.