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NCT Number: NCT04174391

Lifestyles and 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.

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Key information

Conditions

Malignant Tumor of Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Cantabria, Santander, Cantabria, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Presence of circulating tumour cells

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

    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.

  2. Changes in inflammatory markers

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

    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 outcomes

  1. Changes in quality of life

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

    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.

  2. Changes in quality of life

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

    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.

  3. Changes in body mass-index

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

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

Other outcomes

  1. Changes in lipid profile

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

    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.

  2. Changes in lipid profile

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

    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.

  3. Changes in blood glucose

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

    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.

  4. Changes in mammographic density

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

    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.

  5. HOMA-IR and HOMA-beta

    Time frame: average follow-up: 3.5 years

    HOMA-IR and HOMA-beta will be calculated based on serum glucose and insulin concentrations. They will be measured by standard laboratory methods.

Sponsors and collaborators

Lead sponsor

University of Navarra

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: LifeBreast

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2019
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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