Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
研究概览
简要总结
The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.
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
- Single (Investigator)
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
- •> 18 years of age and < 65 years of age
- •BMI > 25
- •Weight < 350 pounds
- •English as a primary language
- •Postmenopausal
- •Invasive ER-positive cancer on biopsy and subsequent definitive surgical therapy
- •Received and Completed standard of care adjuvant therapy (Concurrent endocrine therapy acceptable)
- •6-12 months after completion of therapy (excluding adjuvant endocrine therapy) at time of randomization
排除标准
- •Recurrent breast cancer
- •DCIS only (no invasive component)
- •Taking a Beta Blocker or Verapamil
- •Wheelchair bound
- •Unable to ambulate independently
- •Concurrent uncontrolled medical or psychiatric disorder
- •Open wound
- •Stage IV breast cancer
- •Progression of disease
- •Bilateral mastectomies
研究组 & 干预措施
Exercise Group
The intervention is a structured walking program which will be performed partly in the Pavilion Physical Therapy clinic and partly at home. The participant will be instructed in how hard to exercise, how long to exercise, and how many times in a week to exercise. You will also be instructed in how to exercise safely.
干预措施: Exercise (Behavioral)
No Exercise
These participants will receive standard of care follow up.
结局指标
主要结局
Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
时间窗: 12 months
Number of participants that enroll in the study and actually complete the study
次要结局
- Amount of adipose tissue mass as measured on CT scans in obese breast cancer survivors before and after exercise intervention as a measure of weight loss(12 months)
- IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:(12 months)
研究者
Natale Sheehan
Assistant Professor of Medicine
University of Mississippi Medical Center