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

Conditions
Endocrine Therapy
Vitamin D Deficiency
Breast Cancer
Endocrine Therapy Adverse Reaction
Nutrition Disorders
Obesity
Interventions
Drug: Tamoxifen
Diagnostic Test: Basal
Drug: Anastrozole
Drug: Exemestane
Diagnostic Test: Recurrence
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
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Exclusion Criteria
  • Mental retardation
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
TamoxifenTamoxifenBreast cancer women with tamoxifen treatment
BasalBasalBreast cancer women luminal type without any endocrine treatment (at initial diagnosis)
RecurrenceRecurrenceBreast cancer women luminal type with recurrence of disease during endocrine therapy
AnastrozoleAnastrozoleBreast cancer women with anastrozole treatment
RecurrenceAnastrozoleBreast cancer women luminal type with recurrence of disease during endocrine therapy
ExemestaneExemestaneBreast cancer women with exemestane treatment
RecurrenceTamoxifenBreast cancer women luminal type with recurrence of disease during endocrine therapy
Primary Outcome Measures
NameTimeMethod
Hidroxy Vitamin D ConcentrationOne time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)

Plasma levels of Hidroxy Vitamin D

Body CompositionOne time at enroll with at least 3 months of endocrine therapy

Body composition (bioimpedance)

Secondary Outcome Measures
NameTimeMethod
AnastrozoleOne time. After minimum 3 months of anastrozole treatment

Anastrozole plasma levels

RecurrenceOne 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 levelsOne time. After minimum 3 months of tamoxifen treatment

Tamoxifen plasma levels

ExemestaneOne time. After minimum 3 months of exemestane treatment

Exemestane plasma levels

Trial Locations

Locations (1)

Instituto Jalisciense de Cancerologia

🇲🇽

Guadalajara, Jalisco, Mexico

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