Clinical trial NCT04174391: Lifestyles and Breast Cancer
Official title: Lifestyles for the Prevention of Relapses Among Women with Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Tumor of Breast
Keywords: breast cancer prognosis
Mediterranean diet
extra-virgin olive oil
low-fat diet
Lead sponsor: University of Navarra
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2019-11-22
Enrollment: 766
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Presence of circulating tumour cells
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
measure: Changes in inflammatory markers
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
Secondary outcomes:
measure: Changes in quality of life
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
measure: Changes in quality of life
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
measure: Changes in body mass-index
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
Other outcomes:
measure: Changes in lipid profile
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
measure: Changes in lipid profile
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
measure: Changes in blood glucose
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
measure: Changes in mammographic density
timeFrame: average follow-up: 1.5 years and then extended to 3.5 years
measure: HOMA-IR and HOMA-beta
timeFrame: average follow-up: 3.5 years
Locations:
city: Santander
country: Spain
facility: University of Cantabria
state: Cantabria
city: Pamplona
country: Spain
facility: University of Navarra-Instituto de Investigación Sanitaria de Navarra
state: Navarra
city: Granada
country: Spain
facility: Instituto de Investigación Biosanitaria de Granada ibs.GRANADA
city: Jaen
country: Spain
facility: University of Jaen
Study officials:
affiliation: University of Navarra (IdiSNA)
name: Estefania A Toledo, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cantabria
name: Trinidad Dierssen-Sotos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Investigación Biosanitaria de Granada (ibs.Granada)
name: Jose J Jimenez-Moleon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Salud Carlos III
name: Marina Pollan, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: