Spots Global Cancer Trial Database for Lifestyles and Breast Cancer
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Trial Identification
Brief Title: Lifestyles and Breast Cancer
Official Title: Lifestyles for the Prevention of Relapses Among Women With Early Breast Cancer
Study ID: NCT04174391
Conditions
Study Description
Brief Summary: Background: In Spain, 1 out of every 11 women will have a breast cancer before the age of 85 years and breast cancer is the leading cause of potential years of life lost. The randomized intervention in PREDIMED trail, using Mediterranean diet with free provision of extra virgin olive oil (MedDiet+EVOO) dramatically and significantly reduced the occurrence of cases of postmenopausal breast cancer. Objectives: Assess the efficacy of a nutritional intervention with MedDiet+EVOO for the prevention of relapses among women with early breast cancer. Methods: Randomized, multicenter trial (LifeBreast) among 766 women diagnosed with early breast cancer. Participants will be randomized in a 1:1 ratio to i) MedDiet+EVOO or ii) low-fat diet. Changes in circulating tumor cells, inflammatory biomarkers, oxidative stress and quality of life will be evaluated. The intervention will be delivered by face-to-face interviews with study dietitian, phone calls, and online tools. Participants in the MedDiet+EVOO group will receive 0.5l/week of EVOO and participants in the low-fat group will receive allotments of different foods, both at no cost. Generalized estimating equations will be used to estimate between-group differences in the following outcomes: circulating tumor cells, inflammatory biomarkers, oxidative stress, and quality of life will be evaluated.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Cantabria, Santander, Cantabria, Spain
University of Navarra-Instituto de Investigación Sanitaria de Navarra, Pamplona, Navarra, Spain
Instituto de Investigación Biosanitaria de Granada ibs.GRANADA, Granada, , Spain
University of Jaen, Jaen, , Spain
Contact Details
Name: Estefania A Toledo, MD, MPH, PhD
Affiliation: University of Navarra (IdiSNA)
Role: PRINCIPAL_INVESTIGATOR
Name: Trinidad Dierssen-Sotos, MD, PhD
Affiliation: University of Cantabria
Role: PRINCIPAL_INVESTIGATOR
Name: Jose J Jimenez-Moleon, MD, PhD
Affiliation: Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
Role: PRINCIPAL_INVESTIGATOR
Name: Marina Pollan, Md, PhD
Affiliation: Instituto de Salud Carlos III
Role: PRINCIPAL_INVESTIGATOR
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