NCT01112839已完成不适用
Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 692
- 试验地点
- 8
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
- •BMI between 25 to 45 kg/m2
- •Able to comply with all required study procedures and schedule
排除标准
- •Serious medical condition or psychiatric illness
- •Inability to be moderately physically active
- •Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
- •Currently enrolled in a weight loss program
- •Current use of weight loss medication or supplements
- •Previous surgical procedures for weight reduction
- •Planning weight loss surgery in the next 2 years.
- •6+ months use of meds likely to cause weight gain or prevent weight loss
- •Planned surgical procedure that can impact the conduct of the study
- •Currently pregnant/breastfeeding
- •Planning to become pregnant within the next 2 years
- •Have plans to relocate from area within 2 years
- •Family relative or close friend is a trial staff member or a study participant
- •Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
结局指标
主要结局
Weight loss
时间窗: 2 years
次要结局
- Improvement in fatigue(2 years)
- Improvement in quality of life(2 years)
研究者
Cheryl Rock
Study Principal Investigator
University of California, San Diego
研究点 (8)
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