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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Neoplasms, Recurrence

Intervention / Treatment
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* Behavioral: Diet
* Behavioral: Physical activity
* Behavioral: Minimal diet intervention
* Behavioral: Minimal physical activity intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Lifestyle intervention combining weight control, diet and physical activity | Behavioral: Diet<br>* 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.<br>Behavioral: Physical activity<br>* 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).<br>|
| Sham Comparator: Minimal intervention<br>Minimal diet intervention and minimal physical activity intervention | Behavioral: Minimal diet intervention<br>* Some basic diet recommendations<br>Behavioral: Minimal physical activity intervention<br>* Some basic recommendations on physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to local and distant recurrence | Time between recruitment date and local and distant recurrence date or end of the 5-year follow-up which ever occurs first | 5 years from recruitment day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Recurrence, Motor Activity, Diet, Quality of Life