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.

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Breast Cancer; Nutrition Disorders; Vitamin D Deficiency; Endocrine Therapy; Endocrine Therapy Adverse Reaction
• Intervention / Treatment: Drug: Anastrozole; Drug: Tamoxifen; Drug: Exemestane; Diagnostic test: Basal; Diagnostic test: Recurrence

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: JOSE ALFONSO CRUZ RAMOS, MD; Phone Number: 1523314886313; Email: josealfonsocr@gmail.com

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45180
      • Recruiting
      • Instituto Jalisciense de Cancerologia
      • Contact: JOSE ALFONSO CRUZ RAMOS, MD; Phone Number: 1523314886313; Email: josealfonsocr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Mexican breast cancer woman

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Mental retardation

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anastrozole; Breast cancer women with anastrozole treatment	Drug: Anastrozole; Use of anastrozole for breast cancer recurrence prevention
Tamoxifen; Breast cancer women with tamoxifen treatment	Drug: Tamoxifen; Use of tamoxifen for breast cancer recurrence prevention
Exemestane; Breast cancer women with exemestane treatment	Drug: Exemestane; Use of exemestane for breast cancer recurrence prevention
Basal; Breast cancer women luminal type without any endocrine treatment (at initial diagnosis)	Diagnostic test: Basal; Initial diagnosis of breast cacner by biopsy or mastectomy; Other Names: Breast cancer initial diagnosis
Recurrence; Breast cancer women luminal type with recurrence of disease during endocrine therapy	Drug: Anastrozole; Use of anastrozole for breast cancer recurrence prevention; Drug: Tamoxifen; Use of tamoxifen for breast cancer recurrence prevention; Diagnostic test: Recurrence; Breast cancer recurrence under endocrine therapy; Other Names: Breast cancer recurrence under endoctine therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Jalisciense de Cancerologia
• Collaborators: University of Guadalajara

Publications and helpful links

Helpful Links

• Instituto Jalisciense de Cancerología

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): May 15, 2020
• Study Completion (Anticipated): January 30, 2022

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Vitamin D; Tamoxifen; Gene Expression; Exemestane; Anastrozole; VDR; Nutrients; Adverse; Cytochrome p450
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Breast Neoplasms; Vitamin D Deficiency; Nutrition Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen; Anastrozole; Exemestane
• Other Study ID Numbers: 1/15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No