Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
766 participants
INTERVENTIONAL
2020-05-29
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Mediterranean diet supplemented with extra-virgin olive oil
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
University of Navarra
OTHER
Responsible Party
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Estefania Toledo
Full Professor
Principal Investigators
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Estefania A Toledo, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Navarra (IdiSNA)
Trinidad Dierssen-Sotos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cantabria
Jose J Jimenez-Moleon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
Marina Pollan, Md, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Salud Carlos III
Locations
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University of Cantabria
Santander, Cantabria, Spain
Instituto de Investigación Biosanitaria de Granada ibs.GRANADA
Granada, Granada, Spain
University of Jaen
Jaén, Jaen, Spain
University of Navarra-Instituto de Investigación Sanitaria de Navarra
Pamplona, Navarre, Spain
Countries
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Other Identifiers
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2019.046
Identifier Type: -
Identifier Source: org_study_id