Lifestyles and Breast Cancer
- Conditions
- Malignant Tumor of Breast
- Registration Number
- NCT04174391
- Lead Sponsor
- University of Navarra
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 766
Women with primary pathologically confirmed invasive breast adenocarcinoma in stages I, II or IIIA
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Changes in quality of life 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.
Changes in body mass-index 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
Trial Locations
- Locations (4)
University of Cantabria
🇪🇸Santander, Cantabria, Spain
University of Navarra-Instituto de Investigación Sanitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Instituto de Investigación Biosanitaria de Granada ibs.GRANADA
🇪🇸Granada, Spain
University of Jaen
🇪🇸Jaen, Spain
University of Cantabria🇪🇸Santander, Cantabria, Spain