A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Colorectal Tumors

Treatments: Dietary Supplement: Cohort 1: HFCS (fructose) fed; Dietary Supplement: Cohort 2: D-Xylose (xylose-fed)

Study type: Interventional

Funder types: Other

Identifiers

NCT05136092

21-03023487

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Cohort 1: HFCS (fructose-fed)

Experimental group

Description:

On the day of Surgery, between two and three hours before surgery. Subjects will prepare the sugar solutions (Fructose-containing solution: 250 mL of water containing 41.25 g of D-Fructose and 33.75 g of D-Glucose) by adding 250 ml water to the sugar powder provided by the study team and drink it between two and three hours before surgery. Subjects will be reminded the day before the surgery to drink the solution.

Treatment:

Dietary Supplement: Cohort 1: HFCS (fructose) fed

Cohort 2: D-Xylose (xylose-fed)

Experimental group

Description:

On the day of Surgery, between two and three hours before surgery. Subjects will prepare the sugar solutions (Xylose-containing solution: 250 mL of water containing 41.25 g of D-Xylose and 33.75g of D-Glucose) by adding 250 ml water to the sugar powder provided by the study team and drink it betweentwo and three hours before surgery. Subjects will be reminded the day before the surgery to drink the solution.

Treatment:

Dietary Supplement: Cohort 2: D-Xylose (xylose-fed)