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

Breast Cancer Clinical Trial

— NUTRIBREAST  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389424
• Other study ID #: 1/15
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: January 30, 2022

Study information

• Verified date: May 2020
• Source: Instituto Jalisciense de Cancerologia
• Contact: JOSE ALFONSO CRUZ RAMOS, MD
• Phone: 1523314886313
• Email: josealfonsocr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 30, 2022
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 98 Years

Eligibility

Inclusion Criteria:

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

• Signed consent

Exclusion Criteria:

• Mental retardation

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tamoxifen
Use of tamoxifen for breast cancer recurrence prevention
• Exemestane
Use of exemestane for breast cancer recurrence prevention
• Anastrozole
Use of anastrozole for breast cancer recurrence prevention

Diagnostic Test:
• Basal
Initial diagnosis of breast cacner by biopsy or mastectomy
• Recurrence
Breast cancer recurrence under endocrine therapy

Locations

Country	Name	City	State
Mexico	Instituto Jalisciense de Cancerologia	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Jalisciense de Cancerologia	University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food consumption recall 24 hours (ASA 24)	Automated Self-Administered Recall System	At enroll
Primary	Hidroxy Vitamin D Concentration	Plasma levels of Hidroxy Vitamin D	One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)
Primary	Body Composition	Body composition (bioimpedance)	One time at enroll with at least 3 months of endocrine therapy
Secondary	Tamoxifen plasma levels	Tamoxifen plasma levels	One time. After minimum 3 months of tamoxifen treatment
Secondary	Anastrozole	Anastrozole plasma levels	One time. After minimum 3 months of anastrozole treatment
Secondary	Exemestane	Exemestane plasma levels	One time. After minimum 3 months of exemestane treatment
Secondary	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

External Links

•   Instituto Jalisciense de Cancerología