At a glance
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DIANA-5: Randomized Trial to Test the Efficacy of Dietary Change and Physical Activity to Prevent or Delay the Development of Recurrences in Breast Cancer Patients Estimated to be at High Risk of Recurrence Hormonal and Metabolic Reasons
In Brief
A clinical study evaluating Intervention group on diet and physical activity and Control group: only public recommendation an lifestyle for Breast Cancer Invasive. Completed, enrolled 1,542 participants.
Detailed Summary
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).
Study Details
Timeline
Interventions
The intervention wanted to increase physical activity, controlling weight, promoting healthy diet. 1. Physical activity: achieve and maintain regular participation in a moderate intensity physical activity program of 210 minutes/week (30 min on average per day) over at least 3 days /week; decrease sedentary behaviors by 30 minutes/day on at least 5 days/week 2. Weight control: reducing energy intake relative to expenditure is the primary dietary focus for promoting weight loss in overweight or obese participants, and maintaining a healthy energy balance is the primary focus for normal weight participants. Participants will be encouraged to include whole grains and high-fiber vegetables 3. Healthy diet: reducing calorie intake, through the preferred consumptions of unrefined cereals, pulses and vegetables, reducing high glycemic index food and high insulinemic foods, such as sugar and milk; reducing sources of saturated fat and animal protein (except fish)
1. Invitation leaflet, explaining the rationale of the study and including basic life-style recommendations, based on the 1997 World Cancer Research Fund recommendations (to be updated in 2007) and the Italian National Institute of Nutrition food pyramid. 2. Dissemination of the information on the study by media 3. Yearly follow-up questionnaire on breast events and dietary and physical activity chang