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

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).

Conditions

• Breast Cancer Invasive

Interventions

BEHAVIORAL

Intervention group on diet and physical activity

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)

BEHAVIORAL

Control group: only public recommendation an lifestyle

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

Sponsors & Collaborators

• Associazione Italiana per la Ricerca sul Cancro

  collaborator OTHER

• European Institute of Oncology

  collaborator OTHER

• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

  collaborator OTHER

• Federico II University

  collaborator OTHER

• IRCCS Cancer Referral Center of Basilicata

  collaborator OTHER

• ARNAS Civico Di Cristina Benfratelli Hospital

  collaborator OTHER

• Lega Italiana per la Lotta contro i Tumori

  collaborator OTHER

• Azienda Socio Sanitaria Territoriale di Mantova

  collaborator OTHER

• Ministero della Salute, Italy

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• ANNA VILLARINI, PhD · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-01

Primary Completion

2012-09-30

Completion

2017-09-30