Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity: The ROSA Trial (Phase II, Randomized Controlled Trial for Early Stage Breast Cancer Survivors)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in MetD
研究概览
简要总结
This randomized phase II trial studies how well physical activity works in reducing metabolic dysregulation in obese Latina breast cancer survivors. Physical activity may improve fitness and lessen metabolic disease (such as coronary artery disease, stroke, and type 2 diabetes) risk factors in patients who have breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effects of a 6-month progressive combined training (PCT) program on metabolic dysregulation (MetD) in centrally obese latina breast cancer survivors (LBCS).
SECONDARY OBJECTIVES:
I. To determine whether improved physical fitness and health-related measures from a 6-month PCT program are associated with reductions in MetD in centrally obese LBCS.
II. To determine whether MetD status and physical fitness can be maintained following a 6-month follow-up period and to establish predictors of exercise behavior in LBCS.
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
- •Newly diagnosed (stage I-III) breast cancer
- •Self-identify as Latina
- •Have undergone a lumpectomy or mastectomy
- •Have received and completed neoadjuvant or adjuvant cytotoxic chemotherapy and/or radiation therapy within the past 12 months
- •Have no evidence of cancer disease after treatment (confirmed by their treating physician)
- •Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity; obtains clearance from physician to confirm status)
- •Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 30 kg/m^2 (calculated using height and weight) or body fat > 30% (estimated by bioelectrical impedance), and waist circumference > 35 inches (in)
- •Free from history of chronic disease including severe diabetes (glycosylated hemoglobin [HgA1c] > 7% requiring a pharmacologic intervention), uncontrolled hypertension or thyroid disease (obtains clearance from physician to confirm status)
- •Have not experienced a weight reduction >= 10% within past 6 months; and body weight has remained stable for the past 4 weeks
- •Currently participate in less than 60 minutes of physical activity/week
- •No planned reconstructive surgery with flap repair during trial and follow-up period
- •May use adjuvant endocrine therapy if use will be continued for duration of study period
- •Does not smoke (no smoking during previous 12 months)
- •Willing to travel to the exercise facility at University of Southern California (USC) (parking fees and public transportation permits will be provided)
排除标准
- •Currently pregnant
- •History of chronic disease including uncontrolled diabetes, uncontrolled hypertension or uncontrolled thyroid disease; women using metformin to manage diabetes will be excluded from the trial
- •Weight reduction >= 10% within past 6 months
- •Metastatic disease
- •Planned reconstructive surgery with flap repair during trial and follow-up period
- •Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
结局指标
主要结局
Change in MetD
时间窗: From week 25 to week 49
Insulin resistance (IR) measured by Homeostasis Model Assessment (HOMA) will be assessed from baseline.
次要结局
- Change in cardiorespiratory fitness(Baseline to week 49)
- Change in functional capacity(Baseline to week 49)
- Change in muscle strength(Baseline to week 49)