BMC Cancer. 2013 Aug 23;13:395. doi: 10.1186/1471-2407-13-395.
Physical inactivity and overweight are two known risk factors for postmenopausal breast cancer. Former exercise intervention studies showed that physical activity influences sex hormone levels, known to be related to postmenopausal breast cancer, mainly when concordant loss of body weight was achieved. The question remains whether there is an additional beneficial effect of physical activity when weight loss is reached.
The SHAPE-2 study is a three-armed, multicentre trial. 243 sedentary, postmenopausal women who are overweight or obese (BMI 25-35 kg/m2) are enrolled. After a 4-6 week run-in period, wherein a baseline diet is prescribed, women are randomly allocated to (1) a diet group, (2) an exercise group or (3) a control group. The aim of both intervention groups is to lose an amount of 5-6 kg body weight in 10-14 weeks. The diet group follows an energy restricted diet and maintains the habitual physical activity level. The exercise group participates in a 16-week endurance and strength training programme of 4 hours per week. Furthermore, they are prescribed a moderate caloric restriction. The control group is asked to maintain body weight and continue the run-in baseline diet.
This study will give insight in the potential attributable effect of physical activity on breast cancer risk biomarkers and whether this effect is mediated by changes in body composition, in postmenopausal women. Eventually this may lead to the design of specific lifestyle guidelines for prevention of breast cancer.
The SHAPE-2 study is registered in the register of clinicaltrials.gov, Identifier: NCT01511276.
身体活动不足和超重是绝经后乳腺癌的两个已知风险因素。以前的运动干预研究表明，身体活动会影响性激素水平，已知与绝经后乳腺癌有关，主要是在达到一致的体重减轻时。问题仍然是，在达到减肥目标时，身体活动是否还有额外的益处。
SHAPE-2 研究是一项三臂、多中心试验。招募了 243 名久坐不动、超重或肥胖的绝经后妇女（BMI 为 25-35kg/m2）。经过 4-6 周的适应期，规定了基线饮食，然后将女性随机分配到（1）饮食组、（2）运动组或（3）对照组。两个干预组的目的都是在 10-14 周内减轻 5-6 公斤体重。饮食组遵循能量限制饮食并保持习惯性的身体活动水平。运动组参加 16 周的耐力和力量训练计划，每周 4 小时。此外，他们还被规定适度的热量限制。对照组要求保持体重并继续适应期的基础饮食。
这项研究将深入了解身体活动对乳腺癌风险生物标志物的潜在归因效应，以及这种效应是否通过身体成分的变化来介导，在绝经后妇女中。最终，这可能会导致为预防乳腺癌制定特定的生活方式指南。
SHAPE-2 研究在 clinicaltrials.gov 注册，标识符：NCT01511276。
