Lifestyles and Breast Cancer

Malignant Tumor of Breast Clinical Trial

— LifeBreast  

Official title:

Lifestyles for the Prevention of Relapses Among Women With Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174391
• Other study ID #: 2019.046
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: December 2024

Study information

• Verified date: July 2022
• Source: University of Navarra
• Contact: Estefania A Toledo, MD, MPH, PhD
• Phone: +34 948425600
• Email: etoledo[@]unav.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 766
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Tumor of Breast
• Neoplasms

Intervention

Behavioral:
• Mediterranean 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.
• Low-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.

Locations

Country	Name	City	State
Spain	Instituto de Investigación Biosanitaria de Granada ibs.GRANADA	Granada
Spain	University of Jaen	Jaen
Spain	University of Navarra-Instituto de Investigación Sanitaria de Navarra	Pamplona	Navarra
Spain	University of Cantabria	Santander	Cantabria

Sponsors (2)

Lead Sponsor	Collaborator
University of Navarra	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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 triglycerides using standard enzymatic methods.	average follow-up: 1.5 years
Other	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
Other	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
Primary	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.	average follow-up: 1.5 years
Primary	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
Secondary	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
Secondary	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.	average follow-up: 1.5 years
Secondary	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