Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention

Summary

The main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.

Conditions

• Breast Neoplasms
• Recurrence

Interventions

BEHAVIORAL

Diet

The dietary component, aimed to reduce calorie intake according to individual requirements, will be structured in 1-hour weekly sessions led by trained nutritionists. Sessions will concentrate on teaching participants about food groups, the food pyramid and Mediterranean diet, how to chose, prepare and cook hypo-caloric meals.

BEHAVIORAL

Physical activity

The physical activity component will include two sessions per week led by trained physical activity monitors including aerobic exercise of high/moderate intensity, and instruction about the at-home exercise activities (3 more sessions).

BEHAVIORAL

Minimal diet intervention

Some basic diet recommendations

BEHAVIORAL

Minimal physical activity intervention

Some basic recommendations on physical activity

Sponsors & Collaborators

• Institut Català d'Oncologia

  lead OTHER

Principal Investigators

• Beatriz Cirauqui Cirauqui, MD · Fundació Institut d'Investigació Germans Trias i Pujol

• Sonia Del Barco Berron, MD · Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

• Vanesa Ortega Cebrián, MD · Hospital Vall d'Hebron

• Maria Angeles Arcusa Lanza, MD · Consorci Sanitari de Terrassa

• Antonio Agudo, MD · Institut Català d'Oncología - L'Hospitalet (ICO)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2022-01-31

Completion

2022-01-31

Countries

• Spain

Study Locations