Understanding and Predicting Breast Cancer Events After Treatment
关键词
抽象
描述
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.
日期
| 最后验证: | 11/30/2019 |
| 首次提交: | 05/19/2016 |
| 提交的预估入学人数: | 05/30/2016 |
| 首次发布: | 06/06/2016 |
| 上次提交的更新: | 12/01/2019 |
| 最近更新发布: | 12/03/2019 |
| 实际学习开始日期: | 07/20/2017 |
| 预计主要完成日期: | 11/16/2021 |
| 预计完成日期: | 11/16/2028 |
状况或疾病
干预/治疗
Diagnostic Test: Cardiac MRI
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | 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 - 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 - 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 > 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 - 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 > 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 - Patient does not understand English |
结果
主要结果指标
1. FACT-Fatigue [Baseline]
2. Change in FACT-Fatigue Results [Baseline and 3 months]
3. Change in FACT-Fatigue Results [Baseline, 3 months and 12 months]
4. Change in FACT-Fatigue Results [Baseline, 3 months, 12 months and 24 months]
5. Change in MRI Exam Results [Baseline, 3 months and 24 months]
6. Change in 6 Minute Walk Results [Baseline, 3 months, 12 months and 24 months]
次要成果指标
1. Cohen's 4-item Perceived Stress Scale (PSS) [Baseline, 3 months, 12 months, and 24 months]
2. Cook-Medley Hostility Scale [Baseline]
3. Changes in FACT-Fatigue Results [Baseline, 3 months, 12 months, and 24 months]
4. 6 Minute Walk Results [Baseline, 3 months, 12 months and 24 months]
5. RAND MOS 36-item Short Form Health Survey (SF-36) [Baseline, 3 months, 12 months and 24 months]
6. Center for Epidemiological Studies Depression Scale (CESD-10) [Baseline, 3 months, 12 months and 24 months]
7. Godin Leisure-Time Exercise Questionnaire (LTEQ) [Baseline, 3 months, 12 months and 24 months]
8. PACE Adult Sedentary Behaviors Survey [Baseline, 3 months, 12 months and 24 months]
9. PROMIS Short Form 8A Measure of Sleep Disturbance [Baseline, 3 months, 12 months and 24 months]
10. PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A [Baseline, 3 months, 12 months and 24 months]
11. Walking Efficacy for Duration Scale [Baseline, 3 months, 12 months and 24 months]
12. Chair Stands - Measures Leg Strength [Baseline, 3 months, 12 months and 24 months]
13. Standing Balance Test [Baseline, 3 months, 12 months and 24 months]
14. Gait Speed Test [Baseline, 3 months, 12 months and 24 months]
15. Grip Strength [Baseline, 3 months, 12 months and 24 months]
16. Range of Motion [Baseline, 3 months, 12 months and 24 months]
17. KCCQ-12 Questionnaire [Baseline, 24 months]
其他成果措施
1. B-type natriuretic peptide (BNP) [Baseline and 24 months]
2. Troponin - 1 [Baseline and 3 months]
