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ClinicalTrials.gov ID

NCT02035631

Lead Sponsor

Institut Català d'OncologiaOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

2,000Estimated

Last Update Posted

Jan 14, 2014Estimated

Start Date

Jan 2014

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2022Estimated

Official Title

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

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.

• Breast Neoplasms
• Recurrence

• Diet
• Physical activity
• Minimal diet intervention
• Minimal physical activity intervention

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Institut Català d'OncologiaOTHER

vortega@vhebron.net+34 934894350

aarcusa@cst.cat+34 937003612