Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.
详细描述
Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater risk for recurrence and death compared with lighter women. There have been a few studies examining the effects of different interventions on weight loss in breast cancer survivors but very few have examined the effect of weight loss interventions on circulating levels of markers associated with cancer risk. The overall objective of this proposal is to determine how weight loss affects circulating levels of biomarkers associated with breast cancer risk and recurrence, and quality of life of overweight and obese breast cancer survivors. The central hypothesis is that weight loss will decrease the levels of markers adversely associated with breast cancer and increase quality of life in these women. To test the central hypothesis the following specific aims will be pursued:
- To assess the effects of two different weight loss interventions on biomarkers associated with breast cancer risk and recurrence
- To assess the impact of the weight loss interventions on quality of life and sleep
- To assess the impact of weight loss on measures of bone health
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 44 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal (defined as experiencing at least 12 months without a menstrual period)
- •diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation
- •completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment
- •BMI ≥ 27 kg/m2
- •less than 7 servings of alcohol per week
- •willing to be randomized into either group
- •not planning to move away from the area during the period of study
- •non-smoker
排除标准
- •serious illness requiring medical treatment
- •inability to participate in physical activity due to severe disability
- •history of schizophrenia, psychosis or untreated major depression
- •unwilling to commute to study site once per week
- •failure to provide written informed consent
研究组 & 干预措施
Calorie restricted diet plus exercise
See Intervention Description
干预措施: Calorie restricted diet plus exercise (Other)
Weight management classes
See Intervention Description
干预措施: Weight management classes (Other)
结局指标
主要结局
Change in body weight
时间窗: 0, 6, 12, 18 weeks
次要结局
未报告次要终点