A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The abundance of fructose in tumor extracts
研究概览
简要总结
This proposed study is designed to investigate the specific uptake of fructose by human colorectal tumors. In this study, subjects with colorectal cancer undergoing surgery will receive an oral sugar solution containing fructose or xylose prior to surgery. The tumor will then be resected, and a portion of the tissue will be used to measure the abundance of fructose and xylose. The study hypothesis is that the tumors will take up fructose sugar but not xylose sugar. A comparison of the sugar uptake between the tumor and normal tissues from the adjacent intestinal epithelium and smooth muscle and the liver will be conducted. This proposal will confirm that human colorectal cancer tumors can directly absorb dietary sugars, which has never been demonstrated.
详细描述
This prospective pilot study is designed to investigate the uptake of dietary fructose and xylose by primary human colon tumors. In this study, the recruited patients with colorectal cancer will receive an oral sugar solution containing either Fructose sugar or Xylose sugar before surgery. The tumor will then be resected and a portion of the tumor, normal intestinal tissue, blood, urine, and liver will be used to quantify fructose and xylose.
- Research question Can primary human tumors take up fructose or xylose?
- A statement of the hypothesis The hypothesis is that fructose, but not xylose, can be directly absorbed and stored by primary human colon tumors.
- Design Prospective, non-randomized, pilot, feasibility, single-center, open-label, phase 1, investigator-initiated study to evaluate the uptake of dietary fructose and xylose by primary human colon tumors with 12 subjects in 2 cohorts: Cohort 1: 6 subjects will consume a sugar solution containing fructose and Cohort 2: 6 subjects will consume a sugar solution containing xylose. Eligible subjects that are scheduled to undergo colorectal resection for cancer treatment will be invited to participate in the study in consecutive order from the practice of colorectal surgeons at the time of their preoperative clinic visit. First, Cohort 1 subjects will be enrolled followed by the Cohort 2 subjects.
N=12 Subjects Cohort 1: Fructose sugar solution =6 Subjects Cohort 2: Xylose sugar solution=6 Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of 18 years of age or older, male, and female
- •Subjects with a diagnosis of invasive non-hereditary colonic adenocarcinoma who will be undergoing standard of care (SOC) laparoscopic, robot-assisted, or open surgical resection
- •The subject provides informed consent
排除标准
- •Subjects with a history of uncontrolled diabetes mellitus (A1C >7.0) Type I and Type 2, will be excluded to avoid potential confounders associated with the consumption of a large bolus of sugar (e.g., hyperglycemia and hyperinsulinemia)
- •Inflammatory Bowel Disease (Ulcerative Colitis or Crohn's Disease)
- •Patients on steroid medications
- •Patients with current infectious disease
- •Subjects who do not speak English
结局指标
主要结局
The abundance of fructose in tumor extracts
时间窗: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
The abundance of fructose in tumor extracts assessed by mass spectrometry in the morning after the consumption of oral sugar solutions.
次要结局
- Abundance of Fructose and [13C]-Fructose in the urine(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- Abundance of Fructose and [13C]-Fructose in the liver(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- Abundance of Fructose and [13C]-Fructose in the mesentery tissues(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- The abundance of Xylose and [13C]-Xylose in the blood(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- The abundance of Xylose and [13C]-Xylose in the in the tumor(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- The abundance of Fructose and [13C]-Fructose in the blood(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- Abundance of Fructose and [13C]-Fructose in the intestine(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- The abundance of Xylose and [13C]-Xylose in the urine(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- The abundance of Xylose and [13C]-Xylose in the liver(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- The abundance of Xylose and [13C]-Xylose in the intestinal tissue(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))
- The abundance of Xylose and [13C]-Xylose in the mesentery tissues(Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal))