Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- Serum Hormone Binding Globulin
研究概览
简要总结
This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI at least 25.0 kg/m2
- •Diagnosed with Stage I, II, or III breast cancer within past 5 years
- •Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
- •Not scheduled for or currently undergoing chemotherapy
- •Accessible geographically and by telephone
- •Able to communicate dietary and physical activity data via telephone
- •If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
- •Post-menopausal at diagnosis
排除标准
- •Preliminary bloodwork outside of specified ranges
- •Evidence of renal insufficiency, liver disease, or congestive heart failure
- •Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
- •Recent initiation (< 3 months ago) of thiazides or β-blockers
- •Taking insulin or other antidiabetic drug
- •Other primary or recurrent invasive cancer in past 10 years
- •Unable to commit to study requirements
研究组 & 干预措施
Metformin + lifestyle intervention
干预措施: Metformin (Drug)
Metformin + lifestyle intervention
干预措施: Lifestyle intervention (Behavioral)
Placebo + lifestyle intervention
干预措施: Placebo (Drug)
Placebo + lifestyle intervention
干预措施: Lifestyle intervention (Behavioral)
Metformin + standard dietary guidelines
干预措施: Metformin (Drug)
Metformin + standard dietary guidelines
干预措施: Standard printed dietary guidelines (Behavioral)
Placebo + standard dietary guidelines
干预措施: Placebo (Drug)
Placebo + standard dietary guidelines
干预措施: Standard printed dietary guidelines (Behavioral)
结局指标
主要结局
Serum Hormone Binding Globulin
时间窗: change from baseline to 6 months
Serum hormone binding globulin measured as percent change from baseline
Insulin
时间窗: change from baseline to 6 months
Insulin measured as percent change from baseline
Glucose
时间窗: change from baseline to 6 months
Glucose measured as percent change from baseline
C-reactive Protein
时间窗: change from baseline to 6 months
C-reactive protein measured as percent change from baseline
Bioavailable Testosterone
时间窗: change from baseline to 6 months
Bioavailable testosterone measured as percent change from baseline
次要结局
未报告次要终点
研究者
Ruth E. Patterson
Professor, Department of Family & Preventive Medicine
University of California, San Diego