A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors
NCT ID: NCT05136092
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2022-02-16
2024-09-27
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
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.
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1: HFCS (fructose-fed)
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.
Cohort 1: HFCS (fructose) fed
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 2: D-Xylose (xylose-fed)
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.
Cohort 2: D-Xylose (xylose-fed)
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
Interventions
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Cohort 1: HFCS (fructose) fed
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 2: D-Xylose (xylose-fed)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Inflammatory Bowel Disease (Ulcerative Colitis or Crohn's Disease)
* Patients on steroid medications
* Patients with current infectious disease
* Subjects who do not speak English
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Mehraneh D Jafari, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medicine
New York, New York, United States
Countries
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Other Identifiers
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21-03023487
Identifier Type: -
Identifier Source: org_study_id
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