Clinical trial NCT05136092: A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors
Official title: A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Tumors
Keywords: Fructose
D-Xylose
Primary Human Colorectal Tumors
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective, pilot, feasibility, single-center, non-randomized, open-label, phase 1, investigator-initiated study to evaluate the specific uptake of fructose by human colorectal tumors with 12 subjects in 2 cohorts:

Cohort 1: fructose-fed with 6 subjects Cohort 2: xylose-fed with 6 subjects.

Eligible subjects 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The abundance of fructose in tumor extracts
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
Secondary outcomes:
measure: The abundance of Fructose and [13C]-Fructose in the blood
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: Abundance of Fructose and [13C]-Fructose in the urine
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: Abundance of Fructose and [13C]-Fructose in the liver
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: Abundance of Fructose and [13C]-Fructose in the intestine
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: Abundance of Fructose and [13C]-Fructose in the mesentery tissues
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: The abundance of Xylose and [13C]-Xylose in the blood
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: The abundance of Xylose and [13C]-Xylose in the urine
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: The abundance of Xylose and [13C]-Xylose in the liver
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: The abundance of Xylose and [13C]-Xylose in the intestinal tissue
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: The abundance of Xylose and [13C]-Xylose in the mesentery tissues
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
measure: The abundance of Xylose and [13C]-Xylose in the in the tumor
timeFrame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mehraneh D Jafari, MD
role: PRINCIPAL_INVESTIGATOR
References: