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

NCT05136092 | Completed

• 1 other identifier: 21-03023487
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Tumors

Keywords

Fructose; D-Xylose; Primary Human Colorectal Tumors

Outcome Measures

Primary Outcomes (1)

• The abundance of fructose in tumor extracts

  The abundance of fructose in tumor extracts assessed by mass spectrometry in the morning after the consumption of oral sugar solutions.

  Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)

Secondary Outcomes (11)

• 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 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 intestine

  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)

Study Arms (2)

Cohort 1: HFCS (fructose-fed)

EXPERIMENTAL

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.

Dietary Supplement: Cohort 1: HFCS (fructose) fed

Cohort 2: D-Xylose (xylose-fed)

EXPERIMENTAL

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.

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

Interventions

Cohort 1: HFCS (fructose) fed DIETARY_SUPPLEMENT

Two to 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. Samples collected before surgery: * Blood sample of 5 ml * Urine Samples 5 ml Day of Surgery The anesthesia and surgical procedure will undergo as per regular care. Samples collection at the time the surgical specimen is removed * Blood sample of 5 ml blood will be obtained from the IV line * Tissue samples * 2 Tumor tissue samples 5mmx5mmx5mm, * 2 Intestinal /colon tissue samples 5mmx5mmx5mm * 2 tissue samples from mesentery tissue 5mmx5mmx5mm * Optional Liver Biopsy - a 3-5 mm liver tissue will be obtained for research. * Urine Samples 5 ml

Cohort 1: HFCS (fructose-fed)

Cohort 2: D-Xylose (xylose-fed) DIETARY_SUPPLEMENT

Two to 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 between two and three hours before surgery. Samples collected before surgery: * Blood sample of 5 ml * Urine Samples 5 ml Day of Surgery The anesthesia and surgical procedure will undergo as per regular care. Samples collection at the time the surgical specimen is removed * Blood sample of 5 ml blood will be obtained from the IV line * Tissue samples * 2 Tumor tissue samples 5mmx5mmx5mm, * 2 Intestinal /colon tissue samples 5mmx5mmx5mm * 2 tissue samples from mesentery tissue 5mmx5mmx5mm * Optional Liver Biopsy - a 3-5 mm liver tissue will be obtained for research. * Urine Samples 5 ml

Cohort 2: D-Xylose (xylose-fed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fructose

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Mehraneh D Jafari, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 26, 2021
• Study Start: February 16, 2022
• Primary Completion: August 27, 2024
• Study Completion: September 27, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)