Malignant Tumor of Breast
Conditions
Keywords
breast cancer prognosis, Mediterranean diet, extra-virgin olive oil, low-fat diet
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.
Interventions
BEHAVIORALMediterranean 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.
BEHAVIORALLow-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.
Sponsors
Instituto de Salud Carlos III
University of Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 36-Item Short Form Survey (SF-36) questionnaire. The questionnaire score ranges from 0-100, 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in lipid profile | 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. |
| Changes in blood glucose | 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. |
| Changes in mammographic density | 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. |
| HOMA-IR and HOMA-beta | 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. |
Countries
Spain
Outcome results
None listed