Masala Giovanna, Assedi Melania, Caini Saverio, Ermini Ilaria, Occhini Daniela, Castaldo Maria, Bendinelli Benedetta, Zagni Donatella, Tanzini Donata, Saieva Calogero, Ambrogetti Daniela, Palli Domenico
Tumori. 2014 Jul-Aug;100(4):377-85. doi: 10.1700/1636.17890.
Aims and background. High mammographic breast density (MBD) is an established risk factor for breast cancer (BC). The influence of diet and physical activity (PA) on MBD has long been investigated. In an observational study of a cohort in Florence, we observed inverse associations between consumption of vegetables and olive oil and moderate leisure-time PA and MBD, while high alcohol intake and high glycemic load diets were positively associated with MBD. We set out to investigate whether dietary and PA interventions were able to reduce MBD in postmenopausal women with high MBD (>50%). Methods and study design. The DAMA (Diet, physical Activity and MAmmography) trial, a factorial randomized trial involving healthy nonsmoking postmenopausal women not using hormone replacement therapy and having MBD >50%, is aimed at evaluating the ability of a 24-month intervention based on moderate-intensity PA and/or dietary modification focused on plant foods with a low glycemic load, low in saturated fats and alcohol, and rich in antioxidants and fiber, to reduce the percent MBD. Participants have been randomized to 1 of 4 study arms (diet, PA, diet + PA, control). Dietary and PA habits and anthropometry are collected at baseline and at the end of the intervention phase together with repeated blood and urine samples. The primary outcome of the study is the absolute change in percent MBD as assessed on baseline and follow-up digital mammograms performed in the framework of the local screening program. Results. Of 728 eligible women, 234 (32.1%) agreed to participate. We did not observe any difference across study arms in the baseline distribution of variables of interest related to diet and lifestyle. Conclusions. The DAMA trial may contribute to a better understanding of MBD determinants. This will provide insight into the pathogenesis of BC and may allow the development of strategies for primary prevention focused on high-MBD groups that are easily identifiable in large-scale BC screening programs.
ISRCTN28492718.
目的与背景。乳腺钼靶高密度（MBD）是乳腺癌（BC）的既定风险因素。饮食和身体活动（PA）对MBD的影响长期以来一直受到研究。在一项对佛罗伦萨队列的观察性研究中，我们观察到蔬菜和橄榄油的摄入量、适度的休闲时间PA与MBD之间存在负相关，而高酒精摄入量和高血糖负荷饮食与MBD呈正相关。我们着手研究饮食和PA干预是否能够降低MBD高于50%的绝经后女性的MBD。方法与研究设计。DAMA（饮食、身体活动与乳腺钼靶）试验是一项析因随机试验，纳入未使用激素替代疗法且MBD>50%的健康非吸烟绝经后女性，旨在评估基于中等强度PA和/或饮食调整（重点是低升糖负荷、低饱和脂肪和酒精、富含抗氧化剂和纤维的植物性食物）的24个月干预降低MBD百分比的能力。参与者被随机分配到4个研究组之一（饮食、PA、饮食+PA、对照组）。在基线和干预阶段结束时收集饮食和PA习惯以及人体测量数据，同时收集重复的血液和尿液样本。该研究的主要结局是在当地筛查项目框架内进行的基线和随访数字化乳腺钼靶检查中评估的MBD百分比的绝对变化。结果。在728名符合条件的女性中，234名（32.1%）同意参与。我们未观察到各研究组在与饮食和生活方式相关的感兴趣变量的基线分布上存在任何差异。结论。DAMA试验可能有助于更好地理解MBD的决定因素。这将为BC的发病机制提供见解，并可能有助于制定针对在大规模BC筛查项目中易于识别的高MBD人群的一级预防策略。
ISRCTN28492718。
