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Clinical Trials in Spain / NCT04174391
Active, not recruiting Not applicable

Lifestyles and Breast Cancer

NCT04174391 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Navarra
Phase
Not applicable
Started
2020-05-29
Last updated
2024-12-30

Condition(s) studied

Malignant Tumor of Breast

Investigational drug(s) / intervention(s)

Mediterranean diet supplemented with extra-virgin olive oilLow-fat diet

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Presence of circulating tumour cells — 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.
  • Changes in inflammatory markers — 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.

Trial sites (4)

FacilityCityRegionStatus
University of Cantabria Santander Cantabria
Instituto de Investigación Biosanitaria de Granada ibs.GRANADA Granada Granada
University of Jaen Jaén Jaen
University of Navarra-Instituto de Investigación Sanitaria de Navarra Pamplona Navarre
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04174391 on ClinicalTrials.gov ↗ ← All trials in Spain