AzTrials
AzTrials

Malignant Tumor of BreastLifeBreastNCT04174391

Lifestyles and Breast Cancer

A study testing Mediterranean diet supplemented with extra-virgin olive oil and Low-fat diet in people with Malignant Tumor of Breast, run by University of Navarra at 4 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Malignant Tumor of Breast
What is being tested?
Mediterranean diet supplemented with extra-virgin olive oil and Low-fat diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
766 participants
Where
4 sitesSpain
Study dates
29 May 2020to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women with primary pathologically confirmed invasive breast adenocarcinoma in stages I, II or IIIA

Who cannot join

  • 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
Show all 15Show fewer
  • 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 locations and contacts

4 sites in 1 country.

Spain4 sites

  • Instituto de Investigación Biosanitaria de Granada ibs.GRANADA

    Granada, Granada, 18016

  • University of Jaen

    Jaén, Jaen, 23071

  • University of Navarra-Instituto de Investigación Sanitaria de Navarra

    Pamplona, Navarre, 31008

  • University of Cantabria

    Santander, Cantabria, 39011

Other trials in Spain

About this study

Official title: Lifestyles for the Prevention of Relapses Among Women with Early Breast Cancer

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.

Being tested
Mediterranean diet supplemented with extra-virgin olive oil, Low-fat diet
Keywords
breast cancer prognosis, Mediterranean diet, extra-virgin olive oil, low-fat diet
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediterranean diet supplemented with extra-virgin olive oilBehavioural

    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.

  • Low-fat dietBehavioural

    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.

Study groups in NCT04174391
Study groupRoleWhat they receive
Mediterranean diet supplemented with extra-virgin olive oilExperimentalNot described
Receives: Behavioral: Mediterranean diet supplemented with extra-virgin olive oil
Low-fat dietActive comparatorNot described
Receives: Behavioral: Low-fat diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 ≥1 circulating tumour cell in 10 ml of peripheral blood.

    Measured: average follow-up: 1.5 years and then extended to 3.5 years

  2. 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.

    Measured: average follow-up: 1.5 years and then extended to 3.5 years

Secondary outcomes (3)

  1. 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.

    Measured: average follow-up: 1.5 years and then extended to 3.5 years

  2. Changes in quality of life

    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.

    Measured: average follow-up: 1.5 years and then extended to 3.5 years

  3. 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

    Measured: average follow-up: 1.5 years and then extended to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2019
  2. Study start29 May 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
766 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04174391
Sponsor's protocol ID
2019.046
Acronym
LifeBreast
Status last verified
Dec 2024
First submitted
15 Nov 2019
Last updated
30 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40427618

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean diet supplemented with extra-virgin olive oil and Low-fat diet in people with Malignant Tumor of Breast, run by University of Navarra at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of circulating tumour cells (time frame: average follow-up: 1.5 years and then extended to 3.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04174391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in