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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet supplemented with extra-virgin olive oil | Experimental |
| |
| Low-fat diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet supplemented with extra-virgin olive oil | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of circulating tumour cells | Blood samples will be collected at baseline and yearly thereafter. Presence of circulating tumour cells will be determined with immunohistochemical techniques and defined as ā„1 circulating tumour cell in 10 ml of peripheral blood. | average follow-up: 1.5 years and then extended to 3.5 years |
| Changes in inflammatory markers | 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. | average follow-up: 1.5 years and then extended to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life | 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. | average follow-up: 1.5 years and then extended to 3.5 years |
| Changes in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lipid profile | 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. | average follow-up: 1.5 years and then extended to 3.5 years |
| Changes in lipid profile |
Inclusion Criteria:
Women with primary pathologically confirmed invasive breast adenocarcinoma in stages I, II or IIIA
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Estefania A Toledo, MD, MPH, PhD | University of Navarra (IdiSNA) | Principal Investigator |
| Trinidad Dierssen-Sotos, MD, PhD | University of Cantabria | Principal Investigator |
| Jose J Jimenez-Moleon, MD, PhD | Instituto de InvestigaciĆ³n Biosanitaria de Granada (ibs.Granada) | Principal Investigator |
| Marina Pollan, Md, PhD | Instituto de Salud Carlos III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cantabria | Santander | Cantabria | 39011 | Spain | ||
| Instituto de InvestigaciĆ³n Biosanitaria de Granada ibs.GRANADA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40427618 | Derived | Sanchez-Quesada C, Toledo E, Jimenez-Moleon JJ, Gaforio JJ. Viable Cryopreservation Strategy for Extending the Timeframe of Circulating Tumor Cell Detection in Breast Cancer Clinical Trials. Biomolecules. 2025 May 15;15(5):723. doi: 10.3390/biom15050723. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| Low-fat diet | Behavioral | 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. |
|
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. |
| average follow-up: 1.5 years and then extended to 3.5 years |
| Changes in body mass-index | Weight and height will be ascertained at baseline and yearly thereafter Weight and height will be directly measured in triplicate by trained study personnel | 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 triglycerides using standard enzymatic methods. |
| average follow-up: 1.5 years and then extended to 3.5 years |
| Changes in blood glucose | 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. | average follow-up: 1.5 years and then extended to 3.5 years |
| Changes in mammographic density | 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. | average follow-up: 1.5 years and then extended to 3.5 years |
| HOMA-IR and HOMA-beta | HOMA-IR and HOMA-beta will be calculated based on serum glucose and insulin concentrations. They will be measured by standard laboratory methods. | average follow-up: 3.5 years |
| Granada |
| Granada |
| 18016 |
| Spain |
| University of Jaen | JaƩn | Jaen | 23071 | Spain |
| University of Navarra-Instituto de InvestigaciĆ³n Sanitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |