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

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ClinicalTrials.gov Identifier: NCT05136092
Recruitment Status : Not yet recruiting
First Posted : November 26, 2021
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Colorectal Tumors Dietary Supplement: Cohort 1: HFCS (fructose) fed Dietary Supplement: Cohort 2: D-Xylose (xylose-fed) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.

Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Arm Intervention/treatment
Experimental: Cohort 1: HFCS (fructose-fed)

Day Before Surgery between 09:00 pm and 10:00 pm

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 09:00 pm and 10:00 pm. Subjects will be reminded the day before the surgery to drink the solution.

Dietary Supplement: Cohort 1: HFCS (fructose) fed

Day 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 09:00 pm and 10:00 pm.

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
  • Liver Biopsy - a 3-5 mm liver tissue will be obtained for research.
  • Urine Samples 5 ml

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

Day Before Surgery between 09:00 pm and 10:00 pm

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 09:00 pm and 10:00 pm. Subjects will be reminded the day before the surgery to drink the solution.

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

Day 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 09:00 pm and 10:00 pm.

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
  • Liver Biopsy - a 3-5 mm liver tissue will be obtained for research.
  • Urine Samples 5 ml




Primary Outcome Measures :
  1. The abundance of fructose in tumor extracts [ Time Frame: 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.


Secondary Outcome Measures :
  1. The abundance of Fructose and [13C]-Fructose in the blood [ Time Frame: 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 in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  2. Abundance of Fructose and [13C]-Fructose in the urine [ Time Frame: 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 urine in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  3. Abundance of Fructose and [13C]-Fructose in the liver [ Time Frame: 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 liver tissue in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  4. Abundance of Fructose and [13C]-Fructose in the intestine [ Time Frame: 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 intestine tissue in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  5. Abundance of Fructose and [13C]-Fructose in the mesentery tissues [ Time Frame: 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 mesentery tissue in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  6. The abundance of Xylose and [13C]-Xylose in the blood [ Time Frame: 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 in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  7. The abundance of Xylose and [13C]-Xylose in the urine [ Time Frame: 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 in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  8. The abundance of Xylose and [13C]-Xylose in the liver [ Time Frame: 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 tissue in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  9. The abundance of Xylose and [13C]-Xylose in the intestinal tissue [ Time Frame: 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 in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  10. The abundance of Xylose and [13C]-Xylose in the mesentery tissues [ Time Frame: 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 in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.

  11. The abundance of Xylose and [13C]-Xylose in the in the tumor [ Time Frame: 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 tumor in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136092


Contacts
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Contact: Koianka Trencheva, Dr.PH.,M.S. 646 962 2342 ext 12342 kivanova@med.cornell.edu
Contact: Wooyon Choi 6469622789 woc4001@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Contact: Koianka Trencheva, Dr.PH, MS    646-962-2342    kivanova@med.cornell.edu   
Contact: Wooyon Choi    646 -9622789    woc4001@med.cornell.edu   
Principal Investigator: Alessio Pigazzi, MD, PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Alessio Pigazzi, MD,PhD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT05136092    
Other Study ID Numbers: 21-03023487
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Fructose
D-Xylose
Primary Human Colorectal Tumors
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases