A Pharmacokinetic Study of PEITC in Nutri-Jelly in Healthy Head and Neck Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Time to reach maximum concentration (Tmax)
研究概览
简要总结
This research aims to evaluate the absorption and elimination profile of a bioactive compound PEITC in the matrix of Nutri-jelly - a novel edible nutritious gel. Thus, the investigators conducted a pharmacokinetic study in 12 head and neck cancer survivors. After consumed a serving of Nutri-jelly containing 20 mg PEITC, plasma levels of PEITC at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by liquid chromatography-mass spectrometry (LC-MS/MS). Non-compartmental pharmacokinetic analysis was performed.
详细描述
β-phenylethyl isothiocyanate (PEITC) is a phytochemical found in cruciferous vegetables with anti-cancer properties in vitro and in vivo. However, its pharmacokinetic profile in cancer survivors were unknown. A pharmacokinetic study was conducted in head and neck cancer survivors to evaluate the absorption and elimination profile of PEITC in the matrix of Nutri-jelly - a novel edible nutritious gel. Twelve head and neck cancer survivors consumed a serving of Nutri-jelly containing 20 mg PEITC. Plasma levels of PEITC at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by LC-MS/MS. Non-compartmental pharmacokinetic analysis was performed. Pharmacokinetic parameters including Cmax, Tmax, half-life, clearance were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 20 or above
- •Diagnosed with Head and neck cancer
- •Completed radiation or chemotherapy since at least 4 weeks ago
- •normal physical exam
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •Life expectancy > 3 months
- •Normal kidney function evidenced by serum creatinine, blood urea nitrogen (BUN), no kidney stone, no history of renal dialysis
- •Normal liver function evidenced by serum bilirubin, aspartate transaminase (AST), alanine amino transferase (ALT)
- •not pregnant or breastfeeding
- •no psychiatric symptoms
- •normal vital sign and normal blood chemistry including complete blood count CBC)
- •provide voluntary inform consent
排除标准
- •unable to communicate
- •reject to take Nutri-jelly
- •unable to refrain from vegetable intake for 3 days prior to the test
- •take paracetamol during 2 days prior to the test
- •body weight less than 35 kg or higher than 65 kg
- •oral infection such as Candidiasis interfering with normal oral intake
研究组 & 干预措施
Nutri-PEITC jelly
a single serving of 200 g Nutri-PEITC jelly
干预措施: Nutri-PEITC jelly (Dietary Supplement)
结局指标
主要结局
Time to reach maximum concentration (Tmax)
时间窗: Day 0 - Day 1
The duration to reach maximum plasma concentration of PEITC will be calculated.
Maximum plasma concentration (Cmax) of PEITC
时间窗: Day 0 - Day 1
Plasma concentration of PEITC during 24 hours after intake of Nutri-jelly will be measured and the highest concentration will be identified.
次要结局
- Area under the curve of plasma concentration of PEITC and time(Day 0 - Day 1)