Weight Gain Prevention for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Weight or Percentage (%) Body Fat
研究概览
简要总结
The specific aims of this study are:
- To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Feasibility will be evaluated by examining data on recruitment rate, attendance at intervention sessions, drop-out rates in both study conditions, assessment completion rates, and participant feedback.
- To test the effect of a weight gain prevention program, compared to usual care, on weight, body composition, and biomarkers related to breast cancer prognosis.
- To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors.
- To test the effect of a weight gain prevention program on quality of life variables.
详细描述
Women who are breast cancer patients having chemotherapy before surgery will be invited to participate in the study. You will be allowed to participate in this study only if your physician feels it is safe for you to participate in moderate physical activity, so you will be asked to have him or her complete a form about your health conditions. Information about the cancer and your treatment history will be obtained from your medical records as part of the study.
If you agree to take part in this study, you will asked to come in for 2 visits at the beginning of the study. At your first visit, your resting energy expenditure (REE) will be measured. To test your REE, you will lie down on a bed while wearing a mask to measure the air you let out when you breathe. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). Blood (about 2 teaspoons) will be drawn to measure biomarkers, that may affect breast cancer. You will receive a packet of quality of life questionnaires which will take 45 minutes to complete. You will also receive an actigraph (a small, light-weight device that is worn on the waist during the day) that provides researchers with information on your physical activity. You will be asked to wear the actigraph for 7 days before your second visit. You will be given a diet questionnaire to complete at home. The diet questionnaire will take 60 minutes to complete. You will be asked to bring the actigraph and questionnaires to a baseline study visit.
At the second study visit you will also complete questionnaires about your physical activity.
Your blood pressure and heart rate will be measured. Your physical fitness will be checked by an exercise test done on a treadmill. The exercise test will be monitored by a qualified health care provider and performed by a certified exercise specialist with training in emergency procedures. The exercise intensity will begin at a low level and will be increased over time. The test may be stopped at any time if you experience signs of fatigue or changes in your heart rate, ECG, or blood pressure. You may also stop the test whenever you wish.
Your height, weight, skinfolds, and hip and waist circumference will be measured. Your arm, shoulder, and leg strength will be checked by asking you to stand on a platform and grasp a bar connected to a strain gauge that measures force. Your hip and lower back flexibility will checked using a 'sit and reach' method. Flexibility in your arm will be checked using a goniometer, a small plastic measuring device similar to a ruler.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with newly diagnosed stage II or III breast cancer.
- •Over 18 years of age.
- •Beginning neo-adjuvant chemotherapy at M. D. Anderson (no more than 3 weeks from the administration of the first cycle).
- •Speaks and reads English.
- •Oriented to person, place, and time.
- •Able to come to M. D. Anderson once a week for intervention.
- •Has physician clearance to engage in moderate physical activity.
- •Lives in Harris County, Texas or a county contiguous to Harris County, Texas.
排除标准
- •Have any of the following conditions defined by the American College of Sports Medicine as absolute contraindications to exercise testing (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection).
- •Have any of the following conditions as defined by the American College of Sports Medicine as relative contraindications to exercise testing (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease).
- •Right or left bundle branch block.
- •Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
- •Uncontrolled asthma.
- •Have other medical contraindications as defined by the patient's physician.
- •Have inflammatory breast cancer.
结局指标
主要结局
Weight or Percentage (%) Body Fat
时间窗: Six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery.
次要结局
未报告次要终点