Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Physical Assessment
研究概览
简要总结
Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal tolerated dose: MTD) that can be used in women with breast cancer.
详细描述
3+3 step up design method will be used in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients with operable breast cancer
- •Life expectancy of at least 3 months
- •Adequate organ function
- •No allergy to Vitamin E and TRF
- •Provides consent to participate in trial and adhere to the study protocol
排除标准
- •Receiving concomitant chemotherapy, radiotherapy, hormonal, immune therapy or other investigational drugs
- •Uncontrolled concurrent illness
- •Pregnant / breast feeding women
- •Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications
研究组 & 干预措施
Tocotrienol-rich Fraction (TRF)
Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level.
干预措施: Tocotrienol-rich Fraction (TRF) (Dietary Supplement)
结局指标
主要结局
Physical Assessment
时间窗: For 2 to 4 weeks during supplementation
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Liver Function Test
时间窗: For 2 to 4 weeks during supplementation
Liver enzymes with units of U/L
次要结局
- Bioavailability of TRF(For 2 to 4 weeks during supplementation)
研究者
Nur Aishah Mohd Taib
Professor
University of Malaya