Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in CRP
研究概览
简要总结
The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.
详细描述
Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Consent to participate in study
- •Women aged 18 and older
- •Stage 0 to III breast cancer prior to any treatment and at time of diagnosis
- •Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy
- •Adequate fitness to participate in a physical activity as assessed by the investigator
- •Willing and able to participate in a prescribed exercise program
排除标准
- •Metastatic breast cancer (Stage IV)
- •Initiation of treatment regimen prior to enrollment
- •Treatment for breast cancer not requiring chemotherapy or radiation therapy
- •Patients who are pregnant (negative urine pregnancy test required at baseline to determine eligibility in women of child bearing potential).
- •Currently lactating
- •Do not read, understand, or speak English
- •Eligible participants will not be included if they have:
- •known cardiac disease,
- •uncontrolled hypertension,
- •uncontrolled thyroid disease,
- •diabetes mellitus,
- •mental illness,
- •immune or endocrine abnormality,
- •body weight reduction I10% in past 6 months, and
- •positive exercise stress test.
- •Major surgery within last 6 months that requires exercise restriction
结局指标
主要结局
Changes in CRP
The primary endpoint for this study change in C-reactive protein.
次要结局
- Change in laboratory values
- Change in body composition
- Quality of Life
- Overall Survival