Clinical trial · Interventional
Lifestyles and Breast Cancer
Lifestyles for the Prevention of Relapses Among Women with Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-fat diet | Behavioral | — | UNRESOLVED |
| Mediterranean diet supplemented with extra-virgin olive oil | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mediterranean diet supplemented with extra-virgin olive oil
- interventionNames
- Behavioral: Mediterranean diet supplemented with extra-virgin olive oil
- type
- ACTIVE_COMPARATOR
- label
- Low-fat diet
- interventionNames
- Behavioral: Low-fat diet
Primary outcomes (2)
- measure
- Presence of circulating tumour cells
- timeFrame
- average follow-up: 1.5 years and then extended to 3.5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSanchez-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. PMID 40427618