Understanding and Predicting Breast Cancer Events After Treatment
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
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 - > 18 years old - Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole [Arimidex], letrozole [Femara], exemestane [Aromasin]). - Able to hold breath for 10 seconds - ECOG performance status 0 -2 - 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
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 (patients with tissue expanders will not be excluded) - If previously measured, known LVEF <50% - Symptomatic claustrophobia - Unable to provide informed consent - 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 > 120 mm 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 - Patient does not understand English Inclusion Criteria for Women Free of Cancer for Comparison: - Healthy female without known coronary artery disease > 18 years old - Able to hold breath 10 seconds - ECOG performance status = 0 or 1 - 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 personal history of cancer other than superficial skin cancers - Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery - If previously measured, LVEF ≥ 50% 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 - Unable to provide informed consent - 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 > 120 mm 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 - Patient does not understand English
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Breast Cancer Patients |
Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment. |
|
|
Experimental Non-Cancer Controls |
Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities. |
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More Details
- Status
- Active, not recruiting
- Sponsor
- Wake Forest University Health Sciences
Study Contact
Detailed Description
840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged < 52 vs. > 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected. Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.