Aims and background. The DIANA (Diet and Androgens)-5 study is a multi-institutional
randomized controlled trial of the effectiveness of a diet based on Mediterranean
and macrobiotic recipes and principles, associated with moderate physical
activity, in reducing additional breast cancer events in women with early stage invasive
breast cancer at high risk of recurrence because of metabolic or endocrine milieu.
The intervention is expected to reduce serum insulin and sex hormones, which
were associated with breast prognosis in previous studies.
Methods. Between 2008 and 2010, the study randomly assigned 1208 patients to an
intensive diet and exercise intervention or to a comparison group, to be followed-up
through 2015. General lifestyle recommendations for the prevention of cancer are
given to both groups, and the intervention group is being offered a comprehensive
lifestyle intervention, including cooking classes, conferences, common meals and exercise
sessions. Adherence assessments occurred at baseline and at 12 months and
are planned at 36 and 60 months. They include food frequency diaries, anthropometric
measures, body fat distribution assessed with impedance scale, one.week registration
of physical activity with a multisensor arm-band monitor, metabolic and endocrine
blood parameters. Outcome breast cancer events are assessed through self
report at semi.annual meetings or telephone interview and are validated through
medical record verification.
Results. The randomized groups were comparable for age (51.8 years), proportion of
ER-negative tumors (22%), axillary node metastasis (42%), reproductive variables, tobacco
smoking, blood pressure, anthropometric measurements and hormonal and
metabolic parameters.
Conclusions.DIANA-5 has the potential to establish whether a Mediterranean-macrobiotic
lifestyle may reduce breast cancer recurrences. We will assess evidence of effectiveness,
first by comparing the incidence of additional breast cancer events (local or distant
recurrence, second ipsilateral or contralateral cancer)in the intervention and in the control
group, by an intention-to-treat analysis, and second by analyzing the incidence of
breast cancer events in the total study population by compliance assessment score