Lifestyles and Breast Cancer (LifeBreast)

University of Navarra

Status: Active, not recruiting

Conditions: Malignant Tumor of Breast

Treatments: Behavioral: Mediterranean diet supplemented with extra-virgin olive oil; Behavioral: Low-fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04174391

2019.046

Details and patient eligibility

About

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.

Enrollment: 766 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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766 participants in 2 patient groups

Mediterranean diet supplemented with extra-virgin olive oil

Experimental group

Treatment:

Behavioral: Mediterranean diet supplemented with extra-virgin olive oil

Low-fat diet

Active Comparator group

Treatment:

Behavioral: Low-fat diet