Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Ki67
研究概览
简要总结
Investigators plan to carry out a study to investigate two different pills, Vitamin D and melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with breast cancer. These pills are inexpensive and have very few side effects. A large number of studies using cell cultures and animals have shown that both vitamin D and melatonin can help destroy breast cancer cells. However thoughtful and well-designed studies are necessary on humans to see if they can decrease the spread of breast cancer, and possibly even prevent breast cancer. The proposed study aims to understand the anti-cancer activity of vitamin D and melatonin. This knowledge will assist in creating efficient cancer prevention strategies for Canadians. This study will include women with breast cancer who are being planned for surgery, and will assess whether treatment with vitamin D (dose of 2000 IU per day) in a group of 36 women, or melatonin (dose of 20mg per day) in another group of 36 women, or both pills together in yet another group of 36 women, reduces the spread of cancer cells when compared to a fourth group of 36 women who are treated with sugar pills. To do this we will measure a substance in the blood called Ki67, which provides information about the spread of cancer. Investigators will compare the Ki67 levels in the 4 groups, and all women will receive identical appearing pills so they will not know which treatment they received.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Woman with histologically confirmed invasive breast cancer (ductal, lobular, or mixed)
- •Planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or more weeks
排除标准
- •Less than 18 years of age
- •Stage IIIB or IV disease
- •Inoperable locally advanced or metastatic breast cancer
- •Neoadjuvant chemotherapy is intended
- •Currently taking vitamin D supplements
- •Currently taking melatonin supplements
- •Previously taking vitamin D or melatonin supplements within the last 3 months
- •Currently taking a multivitamin and not willing to discontinue for the duration of the study
- •Hyperparathyroid disease or other calcium disturbance in the past five years
- •Active renal stones in the last six months
- •Renal failure (creatinine > 190 mmol/L)
- •Hypercalcemia (serum calcium > 2.6 mmol/L)
- •Known pregnancy
- •Participation in another clinical trial where the patient receives any other investigational product
- •Unwilling or unable to provide informed consent
研究组 & 干预措施
Melatonin and Vitamin D
干预措施: Melatonin (Drug)
Melatonin and Vitamin D
干预措施: Vitamin D (Drug)
Placebo and Vitamin D
干预措施: Vitamin D (Drug)
Placebo and Vitamin D
干预措施: Placebo (melatonin) (Drug)
Melatonin and Placebo
干预措施: Melatonin (Drug)
Melatonin and Placebo
干预措施: Placebo (vitamin D) (Drug)
Placebo and Placebo
干预措施: Placebo (melatonin) (Drug)
Placebo and Placebo
干预措施: Placebo (vitamin D) (Drug)
结局指标
主要结局
Ki67
时间窗: From time of initial biopsy to the final surgery, which is on average 4 weeks
The primary outcome is the difference in proliferation rate of Ki67 in the tumour (expressed as the percentage of tumour cells expressing Ki67). Ki67 will be measured on the original core biopsy (pre-treatment) and on the lumpectomy/mastectomy specimen (post-treatment).
次要结局
- microRNA(At the time of surgery compared to time of biopsy, which is on average 4 weeks)
研究者
Punam Rana
Principal Investigator
Juravinski Cancer Center