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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Hidroxy Vitamin D Concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 98 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
- •Signed consent
排除标准
- •Mental retardation
研究组 & 干预措施
Anastrozole
Breast cancer women with anastrozole treatment
干预措施: Anastrozole (Drug)
Tamoxifen
Breast cancer women with tamoxifen treatment
干预措施: Tamoxifen (Drug)
Exemestane
Breast cancer women with exemestane treatment
干预措施: Exemestane (Drug)
Basal
Breast cancer women luminal type without any endocrine treatment (at initial diagnosis)
干预措施: Basal (Diagnostic Test)
Recurrence
Breast cancer women luminal type with recurrence of disease during endocrine therapy
干预措施: Tamoxifen (Drug)
Recurrence
Breast cancer women luminal type with recurrence of disease during endocrine therapy
干预措施: Anastrozole (Drug)
Recurrence
Breast cancer women luminal type with recurrence of disease during endocrine therapy
干预措施: Recurrence (Diagnostic Test)
结局指标
主要结局
Hidroxy Vitamin D Concentration
时间窗: One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)
Plasma levels of Hidroxy Vitamin D
Body Composition
时间窗: One time at enroll with at least 3 months of endocrine therapy
Body composition (bioimpedance)
次要结局
- Anastrozole(One time. After minimum 3 months of anastrozole treatment)
- Recurrence(One time. In recurrence after at least 3 months with endocrine therapy)
- Tamoxifen plasma levels(One time. After minimum 3 months of tamoxifen treatment)
- Exemestane(One time. After minimum 3 months of exemestane treatment)