Prevention of Breast Cancer Recurrence Through Weight Control, Diet, &

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02035631
Study type	Interventional
Source	Institut Català d'Oncologia
Contact	Antonio Agudo, MD-PhD
Phone	+34 932607401
Email	a.agudo@iconcologia.net
Status	Not yet recruiting
Phase	Phase 3
Start date	January 2014
Completion date	January 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms