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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 15, 2020

Interventions

  • Drug: Tamoxifen
    • Use of tamoxifen for breast cancer recurrence prevention
  • Drug: Exemestane
    • Use of exemestane for breast cancer recurrence prevention
  • Drug: Anastrozole
    • Use of anastrozole for breast cancer recurrence prevention
  • Diagnostic Test: Basal
    • Initial diagnosis of breast cacner by biopsy or mastectomy
  • Diagnostic Test: Recurrence
    • Breast cancer recurrence under endocrine therapy

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • Mental retardation

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 98 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Jalisciense de Cancerologia
  • Collaborator
    • University of Guadalajara
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • JOSE ALFONSO CRUZ RAMOS, MD, 1523314886313, josealfonsocr@gmail.com

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