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

NCT ID: NCT02035631

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2022-01-31

Brief 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.

Detailed Description

BACKGROUND/MAIN OBJECTIVE: 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. As secondary objectives we aim to assess whether the proposed intervention is able to improve the overall survival or the disease-free survival, as well as quality of life of breast cancer patients. METHODOLOGY: This multicentric randomized controlled trial aims to include 2108 women (1054 per arm), aged up to 75 years, diagnosed with a non-metastatic breast cancer (stage I, II, IIIA) in the participating centres, whose standard treatment was completed within the last 3 months. Participants will be assigned to either an intervention or a control group, and followed for five years. Patients assigned to the control arm will continue with the usual care, including standard guidelines for weight control applied in the centre. Patients in the intervention group will be involved in a lifestyle program with two components. The dietary part will aim to achieve a calorie reduction while maintaining nutritional quality; the physical activity part will include supervised sessions of moderate intensity. Data will be analyzed on an intention to treat basis using time-toevent analysis. HYPOTHESES: We expect a significant reduction in the 5-year cumulative incidence of recurrences (primary outcome) in the intervention group. Furthermore, as secondary outcomes, we expect a significant increase in overall survival and an improvement of quality of life of patients included in the intervention arm.

Conditions

Breast Neoplasms; Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Lifestyle intervention combining weight control, diet and physical activity

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

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.

Physical activity

Intervention Type: BEHAVIORAL

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).

Minimal intervention

Minimal diet intervention and minimal physical activity intervention

Group Type: SHAM_COMPARATOR

Minimal diet intervention

Intervention Type: BEHAVIORAL

Some basic diet recommendations

Minimal physical activity intervention

Intervention Type: BEHAVIORAL

Some basic recommendations on physical activity

Interventions

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Minimal diet intervention

Some basic diet recommendations

Intervention Type: BEHAVIORAL

Minimal physical activity intervention

Some basic recommendations on physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• incident primary breast cancer (ICD-O C50)
• stage at diagnosis I, II, IIIA (or T1-3, N0-N2, M0)
• age at diagnosis below 76 years
• within 3 months since completion of standard treatment (excluding hormonal therapy) and within 15 months since the diagnosis of the disease

Exclusion Criteria

• morbid obesity (BMI >40kg/m²) or underweight (BMI <18kg/m²)
• ischemic heart disease (coronary syndrome, unstable angina or myocardial infarction) or cerebrovascular incident (ischemic or hemorrhagic) during the previous 12 months
• diabetes (only if unstable - glycosylated haemoglobin >9%)
• current medical or surgical treatment to lose weight
• mental illness that would prevent the patient from carrying out the intervention
• logistical factors which would prevent the patient from carrying out the intervention (distance to travel, work or family commitments)
• pregnant or planning pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz Cirauqui Cirauqui, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut d'Investigació Germans Trias i Pujol

Sonia Del Barco Berron, MD

Role: PRINCIPAL_INVESTIGATOR

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Vanesa Ortega Cebrián, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Maria Angeles Arcusa Lanza, MD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de Terrassa

Antonio Agudo, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Català d'Oncología - L'Hospitalet (ICO)

Locations

Fundació Institut d'Investigació Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Institut Catala d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Girona, Girona, Spain

Countries

Spain

Central Contacts

Antonio Agudo, MD-PhD

Role: CONTACT

a.agudo@iconcologia.net

+34 932607401

Noemie Travier, MSc

Role: CONTACT

ntravier@iconcologia.net

+34 932607401

Facility Contacts

Beatriz Cirauqui Cirauqui, MD

Role: primary

bcirauqui@iconcologia.net

+34 934978925

Vanesa Ortega Cebrián, MD

Role: primary

vortega@vhebron.net

+34 934894350

Antonio Agudo, MD

Role: primary

a.agudo@iconcologia.net

+34 932607401

Maria Angeles Arcusa Lanza, MD

Role: primary

aarcusa@cst.cat

+34 937003612

Sonia Del Barco Berron, MD

Role: primary

sdelbarco@iconcologia.net

+34 972225834

Other Identifiers

PREDICOP

Identifier Type: -

Identifier Source: org_study_id