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Lifestyles and Breast Cancer (LifeBreast)

Primary Purpose

Malignant Tumor of Breast

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Mediterranean diet supplemented with extra-virgin olive oil

Low-fat diet

About this trial

This is an interventional other trial for Malignant Tumor of Breast focused on measuring breast cancer prognosis, Mediterranean diet, extra-virgin olive oil, low-fat diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Cantabria
University of Navarra-Instituto de Investigación Sanitaria de NavarraRecruiting
Instituto de Investigación Biosanitaria de Granada ibs.GRANADA
University of Jaen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterranean diet supplemented with extra-virgin olive oil

Low-fat diet

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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

Full Information

NCT ID

NCT04174391

First Posted

November 15, 2019

Last Updated

July 26, 2022

Sponsor

University of Navarra

Collaborators

Instituto de Salud Carlos III

1. Study Identification

Unique Protocol Identification Number

NCT04174391

Brief Title

Lifestyles and Breast Cancer

Acronym

LifeBreast

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 29, 2020 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Navarra

Collaborators

Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Tumor of Breast

Keywords

breast cancer prognosis, Mediterranean diet, extra-virgin olive oil, low-fat diet

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

766 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mediterranean diet supplemented with extra-virgin olive oil

Arm Type

Experimental

Arm Title

Low-fat diet

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Mediterranean diet supplemented with extra-virgin olive oil

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Low-fat diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Presence of circulating tumour cells

Description

Time Frame

average follow-up: 1.5 years

Title

Changes in inflammatory markers

Description

Time Frame

average follow-up: 1.5 years

Secondary Outcome Measure Information:

Title

Changes in quality of life

Description

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.

Time Frame

average follow-up: 1.5 years

Title

Changes in quality of life

Description

Time Frame

average follow-up: 1.5 years

Title

Changes in body mass-index

Description

Weight and height will be ascertained at baseline and yearly thereafter Weight and height will be directly measured in triplicate by trained study personnel

Time Frame

average follow-up: 1.5 years

Other Pre-specified Outcome Measures:

Title

Changes in lipid profile

Description

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.

Time Frame

average follow-up: 1.5 years

Title

Changes in lipid profile

Description

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.

Time Frame

average follow-up: 1.5 years

Title

Changes in blood glucose

Description

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.

Time Frame

average follow-up: 1.5 years

Title

Changes in mammographic density

Description

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.

Time Frame

average follow-up: 1.5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Estefania A Toledo, MD, MPH, PhD

Phone

+34 948425600

Ext

806224

etoledo@unav.es

First Name & Middle Initial & Last Name or Official Title & Degree

Miguel A Martinez-Gonzalez, MD, MPH, PhD

Phone

+34 948425600

Ext

806463

mamartinez@unav.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Estefania A Toledo, MD, MPH, PhD

Organizational Affiliation

University of Navarra (IdiSNA)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Trinidad Dierssen-Sotos, MD, PhD

Organizational Affiliation

University of Cantabria

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jose J Jimenez-Moleon, MD, PhD

Organizational Affiliation

Instituto de Investigación Biosanitaria de Granada (ibs.Granada)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marina Pollan, Md, PhD

Organizational Affiliation

Instituto de Salud Carlos III

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cantabria

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39011

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Trinidad Dierssen-Sotos, MD,PhD

trinidad.dierssen@unican.es

First Name & Middle Initial & Last Name & Degree

Trinidad Dierssen-Sotos, MD,PhD

First Name & Middle Initial & Last Name & Degree

Javier Llorca, MD,PhD

First Name & Middle Initial & Last Name & Degree

Ines Gomez-Acebo, PhD

Facility Name

University of Navarra-Instituto de Investigación Sanitaria de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miguel A Martinez-Gonzalez, MD,MPH,PhD

Phone

+34 94835600

Ext

806463

mamartinez@unav.es

First Name & Middle Initial & Last Name & Degree

Estefania A Toledo, MD,MPH,PhD

First Name & Middle Initial & Last Name & Degree

Miguel A Martinez-Gonzalez, MD,MPH,PhD

First Name & Middle Initial & Last Name & Degree

Jose M Aramendía-Beitia, MD, PhD

First Name & Middle Initial & Last Name & Degree

Cesar I Fernandez-Lazaro, MPH,PhD

First Name & Middle Initial & Last Name & Degree

Andrea Romanos-Nanclares, RD

First Name & Middle Initial & Last Name & Degree

Rodrigo Sánchez Bayona, MD,PhD

First Name & Middle Initial & Last Name & Degree

Inmaculada Aguilera Buenosvinos, MSc

Facility Name

Instituto de Investigación Biosanitaria de Granada ibs.GRANADA

City

Granada

ZIP/Postal Code

18016

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose J Jimenez-Moleon, MD, PhD

jjmoleon@ugr.es

First Name & Middle Initial & Last Name & Degree

Jose J Jimenez-Moleon, MD, PhD

First Name & Middle Initial & Last Name & Degree

Rocio Barrios, PhD

First Name & Middle Initial & Last Name & Degree

Pablo Torne-Poyatos, MD, PhD

First Name & Middle Initial & Last Name & Degree

Juan Mozas-Moreno, MD, PhD

First Name & Middle Initial & Last Name & Degree

Carmen Amezcua-Prieto, PhD

First Name & Middle Initial & Last Name & Degree

Inmaculada Salcedo-Bellido, PhD

First Name & Middle Initial & Last Name & Degree

Rocio Olmedo-Requena, PhD

Facility Name

University of Jaen

City

Jaen

ZIP/Postal Code

23071

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose J Gaforio, MD, PhD

jgaforio@ujaen.es

First Name & Middle Initial & Last Name & Degree

Jose J Gaforio, MD, PhD

First Name & Middle Initial & Last Name & Degree

Cristina Sanchez-Quesada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Lifestyles and Breast Cancer

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