Vitamin D and Breast Cancer: Does Weight Make a Difference?
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene
研究概览
简要总结
This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight.
详细描述
Vitamin D3 (cholecalciferol, colecalciferol) is one of type of vitamin D which is made by the skin when exposed to sunlight; it is also found in some foods and can be taken as a dietary supplement. It is used to treat and prevent vitamin D deficiency and associated diseases, including rickets. Vitamin D3 may have a role obesity and cancer biology. In the body, Vitamin D3 is metabolized to the active form 1,25-dihydroxycholecalciferol (calcitriol, 1,25-(OH)2vitamin D3).
This protocol is a randomized, controlled, and blinded clinical trial in obese and non-obese breast cancer patients in whom the effects of vitamin D supplementation will be evaluated in the neoadjuvant setting. Changes in biomarker expression levels in blood will be assessed from baseline to post-treatment (post-surgery).
Per protocol (see title), the treatment groups are defined as those participants with body mass index (BMI) ≤ 25 ("non-obese") and > 25 ("obese"). Within each treatment group, dose of Vitamin D3 was stratified between 400 IU/day (control) and 10,000 IU/day (experimental). All analyses were typically conducted between BMI cohorts stratified by Vitamin D3 dose.
Protocol Primary Objective: "To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non obese subjects diagnosed with breast cancer."
Protocol Secondary Objectives: "To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by serum biomarkers of insulin resistance and adipokine secretion in obese and non obese subjects diagnosed with breast cancer."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
- •No prior therapy for breast cancer.
- •Age 18 years or older.
- •Any menopausal status
- •Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
- •Availability of tissue blocks from initial core needle biopsy.
- •Signed informed consent.
- •Willing to discontinue use of all supplements containing Vitamin D for the duration of the study, and take only the Vitamin D provided by the study.
排除标准
- •Presence of any Metastatic lesion.
- •History of parathyroid disease, hypercalcemia, or kidney stones.
- •History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor therapy.
- •Receiving metformin.
- •History of renal failure requiring dialysis or kidney transplantation.
- •Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
- •Patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin D intervention
- •Any condition potentially interfering with subjects ability to comply with taking study medication.
- •Any medical condition that would potentially interfere with vitamin D absorption.
- •Current participation in another research study that would increase risk to subject, in the opinion of the investigators.
- •Patients currently taking more than 2000 IU of Vitamin D.
研究组 & 干预措施
Non-obese (Body Mass Index ≤ 25)
Non-obese participants receive Vitamin D at 400 or 10,000 IU/day
干预措施: Vitamin D (Drug)
Obese (Body Mass Index > 25)
Obese participants receive Vitamin D at 400 or 10,000 IU/day
干预措施: Vitamin D (Drug)
结局指标
主要结局
Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene
时间窗: up to 6 weeks
To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non-obese subjects diagnosed with breast cancer. IGFBP-3 is an endocrine factors. Insulin-like growth factor-binding protein 3 (IGFBP-3) gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and \> 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect.
次要结局
- Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene(up to 6 weeks)
- Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene(up to 6 weeks)
研究者
Melinda Telli
Assistant Professor of Medicine
Stanford University