Energy Balance and Breast Cancer Aspects-II Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 545
- 试验地点
- 3
- 主要终点
- VO2max
研究概览
简要总结
The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise program comprised of strength and endurance training among newly diagnosed breast cancer patients undergoing adjuvant therapy, will influence cardiopulmonary function. Secondary aims are to determine whether the 12 month exercise program will influence factors associated with metabolic profile, tumor growth, disease-free survival, overall mortality and breast cancer specific mortality. Furthermore, the effect on QoL parameters, and dietary factors will be assessed and evaluated.
详细描述
The EBBA (Energy Balance and Breast cancer Aspects)-II study is a randomized clinical 12 month physical activity intervention trial, including female breast cancer patients diagnosed with histologically verified invasive cancer stage I-II or carcinoma in situ (DCIS/LCIS) grade 3.
- Participants are randomized to either control or intervention group 10 days +/- 2 days after surgery. The intervention start 3 weeks after surgery and continue throughout adjuvant treatments given (chemotherapy, radiation, endocrine therapy etc). The intervention group receive a detailed training program based on their own ventilatory maximal oxygen consumption (VO2max) at baseline. They meet for supervised training sessions in groups for 60 minutes x 2/ week during 12 months. In addition, they are informed to exercise at home for at least of total 120 minutes weekly aiming to perform a total of 240 minutes exercise, weekly. The patients in the control group receive standard of care without any restrictions regarding exercise.
- All participants will undergo a series of measurements before surgery, after surgery, 6 months and after the 12 months exercise intervention trial. Clinical measurements will include anthropometric measurements, fasting blood, fecal and urine samples and cardiopulmonary exercise test (CPET). Complete questionnaires (food diary (PFD)/food frequency questionnaires (FFQ), quality of life (QoL)).
- All participants will come to clinical examination and fasting blood sampling after 2, 3, 5 and 10 years follow up.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Newly diagnosed DCIS grade 3 or invasive breast cancer stage I, II, histologically verified.
- •All ethnic groups, but participants have to speak and write the Norwegian language.
- •Ability to join and maintain an intervention for 12 months
排除标准
- •Verified heart disease
- •Dysregulated diabetes mellitus or thyroid disorders
- •Muscular and skeletal or other disorders excluding regular physical activity performance
- •Body Mass Index >40 kg/m2
- •Previous surgical treatment for obesity
- •Travel distance >1.5 hour from home to study site
结局指标
主要结局
VO2max
时间窗: Baseline,12 months
Change in VO2max from baseline to 12 months
次要结局
- BMI(Baseline,12 months)
- HbA1c(Baseline,12 months)
- C-reactive Protein (CRP)(Baseline,12 months)
- Total fat(Baseline,12 months)
- Energy from food diary(Baseline,12 months)
- Systolic blood pressure(Baseline,12 months)
- Diastolic blood pressure(Baseline,12 months)
- Total cholesterol(Baseline,12 months)
- LDL cholesterol(Baseline,12 months)
- HDL cholesterol(Baseline,12 months)
- Waist circumference(Baseline,12 months)
- Total cholesterol/HDL cholesterol(Baseline,12 months)
- Insulin(Baseline,12 months)
- Triglycerides(Baseline,12 months)
- Heart rate(Baseline,12 months)
- Truncated fat(Baseline,12 months)
- Metabolic syndrome(12 months)
研究者
Inger Thune
Professor
Oslo University Hospital