Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer
NUTRIBREAST
Evaluation of the Relationship Between Drug Therapy, Food Consumption, Body Composition and Plasma Micronutients Levels With the Expression of Genes Related to Metabolism, Aging and Immunity in Women With Breast Cancer.
1 other identifier
observational
300
1 country
1
Brief Summary
The protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 7, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedMay 15, 2020
May 1, 2020
2.7 years
May 7, 2020
May 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hidroxy Vitamin D Concentration
Plasma levels of Hidroxy Vitamin D
One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)
Body Composition
Body composition (bioimpedance)
One time at enroll with at least 3 months of endocrine therapy
Secondary Outcomes (4)
Tamoxifen plasma levels
One time. After minimum 3 months of tamoxifen treatment
Anastrozole
One time. After minimum 3 months of anastrozole treatment
Exemestane
One time. After minimum 3 months of exemestane treatment
Recurrence
One time. In recurrence after at least 3 months with endocrine therapy
Other Outcomes (1)
Food consumption recall 24 hours (ASA 24)
At enroll
Study Arms (5)
Anastrozole
Breast cancer women with anastrozole treatment
Tamoxifen
Breast cancer women with tamoxifen treatment
Exemestane
Breast cancer women with exemestane treatment
Basal
Breast cancer women luminal type without any endocrine treatment (at initial diagnosis)
Recurrence
Breast cancer women luminal type with recurrence of disease during endocrine therapy
Interventions
Initial diagnosis of breast cacner by biopsy or mastectomy
Breast cancer recurrence under endocrine therapy
Eligibility Criteria
Mexican breast cancer woman
You may qualify if:
- Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
- Signed consent
You may not qualify if:
- Mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto Jalisciense de Cancerologialead
- University of Guadalajaracollaborator
Study Sites (1)
Instituto Jalisciense de Cancerologia
Guadalajara, Jalisco, 45180, Mexico
Related Links
Biospecimen
Blood samples to obtain serum and DNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2020
First Posted
May 15, 2020
Study Start
September 1, 2017
Primary Completion
May 15, 2020
Study Completion
January 30, 2022
Last Updated
May 15, 2020
Record last verified: 2020-05