Lifestyles and Breast Cancer (LifeBreast)

Lifestyles for the Prevention of Relapses Among Women with Early Breast Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Tumor of Breast
• Intervention / Treatment: Behavioral: Mediterranean diet supplemented with extra-virgin olive oil; Behavioral: Low-fat diet

• Study Type: Interventional
• Enrollment (Estimated): 766
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18016
    • Instituto de Investigación Biosanitaria de Granada ibs.GRANADA
  • Jaen, Spain, 23071
    • University of Jaén
  • Cantabria
    • Santander, Cantabria, Spain, 39011
      • University of Cantabria
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • University of Navarra-Instituto de Investigación Sanitaria de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Women with primary pathologically confirmed invasive breast adenocarcinoma in stages I, II or IIIA

Exclusion Criteria:

• breast cancer recurrence
• in situ CDIS or LDIS
• inability or unwillingness to give written informed consent
• difficulty to comply with the intervention
• lack of willpower to change their diet (using the models of Prochaska and DiClemente)
• inability or unwillingness to communicate with study personnel
• medical condition that prevents the intervention (digestive disease with fat intolerance; severe psychiatric, neurological or endocrine disease; or allergy or hypersensitivity to any of the key foods of the intervention (EVOO or nuts) or impossibility to follow a Mediterranean diet and/or EVOO intake
• immunodeficiency or HIV-positive status
• concomitant condition that limits life-expectancy to less than 1 year
• difficulty or impossibility for an adequate follow-up
• institutionalized patients with lack of autonomy
• impossibility for attending group sessions and yearly follow-up visits or for telephone contact
• usual alcohol consumption >80 g/d
• BMI>40
• Patients with acute infection or inflammatory process (e.g. pneumonia) may be included in the study three months after the resolution of the infectious symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean diet supplemented with extra-virgin olive oil	Behavioral: Mediterranean diet supplemented with extra-virgin olive oil; Dietary advice on how to follow a Mediterranean diet will be received by the intervention group. The intervention will be delivered mainly by phone (1 call/month), internet and written materials. Also, there will be yearly face-to-face individual interviews and biannual group sessions. A total of 0.5l/week of EVOO for free will be received by participants of this group. In addition, advice on physical activity will be provided.
Active Comparator: Low-fat diet	Behavioral: Low-fat diet; Dietary advice on how to follow a low-fat diet will be received by the intervention group. The intervention will be delivered mainly by phone (1 call/month), internet and written materials. Also, there will be yearly face-to-face individual interviews and biannual group sessions. Allotments of commercial foods - equivalent to the extra-virgin olive oil allotment - will be received by participants of this group for free. In addition, advice on physical activity will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of circulating tumour cells	Blood samples will be collected at baseline and yearly thereafter. Presence of circulating tumour cells will be determined with immunohistochemical techniques and defined as ≥1 circulating tumour cell in 10 ml of peripheral blood.	average follow-up: 1.5 years and then extended to 3.5 years
Changes in inflammatory markers	Changes in the inflammatory profile of the participants as plasma cytokines - such as IL-6 -, changes in oxidative stress response with the lipid peroxidation test (LPO test), and changes in DNA damage with electrophoresis single-cell alkaline (comet Assay) in buffy coat will be assessed.	average follow-up: 1.5 years and then extended to 3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life	Changes in quality of life will be assessed with the 36-Item Short Form Survey (SF-36) questionnaire. The questionnaire score ranges from 0-100, with higher score meaning better outcomes.	average follow-up: 1.5 years and then extended to 3.5 years
Changes in quality of life	Changes in quality of life will be assessed with the the Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire. The questionnaire score ranges from 0-148, with higher score meaning better outcomes.	average follow-up: 1.5 years and then extended to 3.5 years
Changes in body mass-index	Weight and height will be ascertained at baseline and yearly thereafter Weight and height will be directly measured in triplicate by trained study personnel	average follow-up: 1.5 years and then extended to 3.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lipid profile	Blood samples will be collected at baseline and yearly thereafter. Blood samples will be obtained after an overnight fast to determine levels of cholesterol using standard enzymatic methods.	average follow-up: 1.5 years and then extended to 3.5 years
Changes in lipid profile	Blood samples will be collected at baseline and yearly thereafter. Blood samples will be obtained after an overnight fast to determine levels of triglycerides using standard enzymatic methods.	average follow-up: 1.5 years and then extended to 3.5 years
Changes in blood glucose	Blood samples will be collected at baseline and yearly thereafter. Blood samples will be obtained after an overnight fast to determine levels of fasting blood glucose using standard enzymatic methods.	average follow-up: 1.5 years and then extended to 3.5 years
Changes in mammographic density	All available digital mammograms during follow-up of the contralateral non-affected breast of each woman will be collected, they will be read by an experienced radiologist in a blind way (without knowing the allocation group) using the DM-Scan program.	average follow-up: 1.5 years and then extended to 3.5 years
HOMA-IR and HOMA-beta	HOMA-IR and HOMA-beta will be calculated based on serum glucose and insulin concentrations. They will be measured by standard laboratory methods.	average follow-up: 3.5 years

Collaborators and Investigators

• Sponsor: University of Navarra
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Estefania A Toledo, MD, MPH, PhD, University of Navarra (IdiSNA); Principal Investigator: Trinidad Dierssen-Sotos, MD, PhD, University of Cantabria; Principal Investigator: Jose J Jimenez-Moleon, MD, PhD, Instituto de Investigación Biosanitaria de Granada (ibs.Granada); Principal Investigator: Marina Pollan, Md, PhD, Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer prognosis; Mediterranean diet; extra-virgin olive oil; low-fat diet
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2019.046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No