Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer
- Conditions
- Endocrine TherapyVitamin D DeficiencyBreast CancerEndocrine Therapy Adverse ReactionNutrition DisordersObesity
- Interventions
- Registration Number
- NCT04389424
- Lead Sponsor
- Instituto Jalisciense de Cancerologia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
- Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
- Signed consent
Read More
Exclusion Criteria
- Mental retardation
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tamoxifen Tamoxifen Breast cancer women with tamoxifen treatment Basal Basal Breast cancer women luminal type without any endocrine treatment (at initial diagnosis) Recurrence Recurrence Breast cancer women luminal type with recurrence of disease during endocrine therapy Anastrozole Anastrozole Breast cancer women with anastrozole treatment Recurrence Anastrozole Breast cancer women luminal type with recurrence of disease during endocrine therapy Exemestane Exemestane Breast cancer women with exemestane treatment Recurrence Tamoxifen Breast cancer women luminal type with recurrence of disease during endocrine therapy
- Primary Outcome Measures
Name Time Method Hidroxy Vitamin D Concentration One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy) Plasma levels of Hidroxy Vitamin D
Body Composition One time at enroll with at least 3 months of endocrine therapy Body composition (bioimpedance)
- Secondary Outcome Measures
Name Time Method 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
Tamoxifen plasma levels One time. After minimum 3 months of tamoxifen treatment Tamoxifen plasma levels
Exemestane One time. After minimum 3 months of exemestane treatment Exemestane plasma levels
Trial Locations
- Locations (1)
Instituto Jalisciense de Cancerologia
🇲🇽Guadalajara, Jalisco, Mexico