Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04389424

Acronym

NUTRIBREAST

Enrollment

300

Registered

2020-05-15

Start date

2017-09-01

Completion date

2022-01-30

Last updated

2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Endocrine Therapy, Endocrine Therapy Adverse Reaction, Vitamin D Deficiency, Nutrition Disorders, Obesity

Keywords

Vitamin D, Adverse, Cytochrome p450, VDR, Nutrients, Gene Expression, Tamoxifen, Anastrozole, Exemestane

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.

Interventions

DRUGTamoxifen

Use of tamoxifen for breast cancer recurrence prevention

DRUGExemestane

Use of exemestane for breast cancer recurrence prevention

DRUGAnastrozole

Use of anastrozole for breast cancer recurrence prevention

DIAGNOSTIC_TESTBasal

Initial diagnosis of breast cacner by biopsy or mastectomy

DIAGNOSTIC_TESTRecurrence

Breast cancer recurrence under endocrine therapy

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 98 Years

Healthy volunteers

Inclusion criteria

* Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy * Signed consent

Exclusion criteria

* Mental retardation

Design outcomes

Primary

Measure	Time frame	Description
Body Composition	One time at enroll with at least 3 months of endocrine therapy	Body composition (bioimpedance)
Hidroxy Vitamin D Concentration	One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)	Plasma levels of Hidroxy Vitamin D

Secondary

Measure	Time frame	Description
Anastrozole	One time. After minimum 3 months of anastrozole treatment	Anastrozole plasma levels
Recurrence	One time. In recurrence after at least 3 months with endocrine therapy	Recurrence of breast cancer after endocrine therapy with tamoxifen or aromatase inhibitors
Exemestane	One time. After minimum 3 months of exemestane treatment	Exemestane plasma levels
Tamoxifen plasma levels	One time. After minimum 3 months of tamoxifen treatment	Tamoxifen plasma levels

Other

Measure	Time frame	Description
Food consumption recall 24 hours (ASA 24)	At enroll	Automated Self-Administered Recall System

Countries

Mexico

Contacts

Primary ContactJOSE ALFONSO CRUZ RAMOS, MD

josealfonsocr@gmail.com1523314886313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026