Trial of Diet, Physical Activity and Breast Cancer Recurrences: the DIANA-5 Study

The investigators recruited 1542 Breast Cancer (BC) patients and to randomize the participants in two groups: 773 have received standard recommendations for healthy lifestyle without, however, any active support; 700 have received a combination of individual and group contacts over the course of one year, including kitchen courses, gym and dance classes, common meals and reinforcing meetings, with emphasis on a comprehensive dietary change including low saturated fat and low refined carbohydrates, and high whole grain cereals and pulses consumption. Compliance have been monitored through weight change and plasma glucose, triglycerides, cholesterol and testosterone. The main analysis will be by intention to treat. Under the hypothesis of reducing recurrence rate by 25% or 33% the statistical power of the study is 80% or, respectively, 90%, (P\<0.05, 5-year follow-up).