Lifestyles and Breast Cancer

NCT04174391 | Active Not Recruiting

• 1 other identifier: 2019.046
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 4

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.

Conditions

Malignant Tumor of Breast

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in quality of life

  average follow-up: 1.5 years and then extended to 3.5 years

• Changes in quality of life

  average follow-up: 1.5 years and then extended to 3.5 years

• Changes in body mass-index

  average follow-up: 1.5 years and then extended to 3.5 years

Other Outcomes (5)

• Changes in lipid profile

  average follow-up: 1.5 years and then extended to 3.5 years

• Changes in lipid profile

  average follow-up: 1.5 years and then extended to 3.5 years

• Changes in blood glucose

  average follow-up: 1.5 years and then extended to 3.5 years

Study Arms (2)

Mediterranean diet supplemented with extra-virgin olive oil

EXPERIMENTAL

Behavioral: Mediterranean diet supplemented with extra-virgin olive oil

Low-fat diet

ACTIVE COMPARATOR

Behavioral: Low-fat diet

Interventions

Mediterranean diet supplemented with extra-virgin olive oil BEHAVIORAL

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.

Mediterranean diet supplemented with extra-virgin olive oil

Low-fat diet BEHAVIORAL

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.

Low-fat diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Navarra: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (4)

University of Cantabria

Santander, Cantabria, 39011, Spain

Location

Instituto de Investigación Biosanitaria de Granada ibs.GRANADA

Granada, Granada, 18016, Spain

Location

University of Jaen

Jaén, Jaen, 23071, Spain

Location

University of Navarra-Instituto de Investigación Sanitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 22, 2019
• Study Start: May 29, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

ES (4)