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Brief Title: Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention
Official Title: Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention
Study ID: NCT02035631
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Fundació Institut d'Investigació Germans Trias i Pujol, Badalona, Barcelona, Spain
Institut Catala d'Oncologia - L'Hospitalet, L'Hospitalet de llobregat, Barcelona, Spain
Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Girona, , Spain
Name: Beatriz Cirauqui Cirauqui, MD
Affiliation: Fundació Institut d'Investigació Germans Trias i Pujol
Role: PRINCIPAL_INVESTIGATOR
Name: Sonia Del Barco Berron, MD
Affiliation: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Role: PRINCIPAL_INVESTIGATOR
Name: Vanesa Ortega Cebrián, MD
Affiliation: Hospital Vall d'Hebron
Role: PRINCIPAL_INVESTIGATOR
Name: Maria Angeles Arcusa Lanza, MD
Affiliation: Consorci Sanitari de Terrassa
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Agudo, MD
Affiliation: Institut Català d'Oncología - L'Hospitalet (ICO)
Role: PRINCIPAL_INVESTIGATOR