Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
研究概览
简要总结
The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.
详细描述
Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts.
Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Invasive breast carcinoma
- •Clinical conditions for breast surgery
- •No previous neoadjuvant treatment for breast cancer
- •Agreement to take part in the study and sign the informed consent
排除标准
- •History of hypercalcemia or nephrolithiasis
- •Current use of corticosteroids, vitamin D supplementation, HRT
- •Previous chemotherapy, hormonotherapy or radiotherapy
- •Parathyroid disease
- •Absence of clinical condition to receive supplementation
研究组 & 干预措施
calcitriol
calcitriol supplementation (0.25 mcg 2x/d)
干预措施: Calcitriol (Drug)
结局指标
主要结局
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
时间窗: 30 days
次要结局
- Follow-up for 5 years(5 years)
研究者
Eduardo Carneiro de Lyra
MD, PhD
University of Sao Paulo General Hospital