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

Phase 3

• Conditions: Breast Neoplasms; Recurrence
• Interventions: Behavioral: Minimal diet intervention; Behavioral: Diet; Behavioral: Minimal physical activity intervention; Behavioral: Physical activity

• Registration Number: NCT02035631
• Lead Sponsor: Institut Català d'Oncologia

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.

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-13
• Last Update Submitted: 2014-01-13
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal intervention	Minimal diet intervention	Minimal diet intervention and minimal physical activity intervention
Minimal intervention	Minimal physical activity intervention	Minimal diet intervention and minimal physical activity intervention
Intervention	Diet	Lifestyle intervention combining weight control, diet and physical activity
Intervention	Physical activity	Lifestyle intervention combining weight control, diet and physical activity

Primary Outcome Measures

Name	Time	Method
Time to local and distant recurrence	5 years from recruitment day	Time between recruitment date and local and distant recurrence date or end of the 5-year follow-up which ever occurs first

Secondary Outcome Measures

Name	Time	Method
Quality of life	Baseline, one year and three years	Quality of life assessments using the SF36, the FACIT (fatigue questionnaire) and the HADS (Anxiety and depression)
Overall survival	5 years	Time between recruitment date and death date or end of 5-year follow-up which ever occurs first
Disease free survival	5 years	Time between recruitment date and recurrence (local or distant) or death or end of 5-year follow-up which ever occurs first

Trial Locations

Locations (5)

Institut Catala d'Oncologia - L'Hospitalet; 🇪🇸 L'Hospitalet de llobregat, Barcelona, Spain

Fundació Institut d'Investigació Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta; 🇪🇸 Girona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain