Colorectal TumorsNCT05136092
A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors
A study testing Cohort 1: HFCS (fructose) fed and Cohort 2: D-Xylose (xylose-fed) in people with Colorectal Tumors, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Tumors
- What is being tested?
- Cohort 1: HFCS (fructose) fed and Cohort 2: D-Xylose (xylose-fed)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2022to 27 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Colorectal Tumors
- Being tested
- Cohort 1: HFCS (fructose) fed, Cohort 2: D-Xylose (xylose-fed)
- Keywords
- Fructose, D-Xylose, Primary Human Colorectal Tumors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1: HFCS (fructose) fedDietary 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 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Cohort 2: D-Xylose (xylose-fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The abundance of Fructose and [13C]-Fructose in the blood in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.
Measured: 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
The abundance of Fructose and [13C]-Fructose in the urine in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
The abundance of Xylose and [13C]-Xylose in the blood in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.
Measured: 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
The abundance of Xylose and [13C]-Xylose in the urine in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 in the tumor
The abundance of Xylose and [13C]-Xylose in the tumor in the morning after the consumption of oral sugar solutions assessed by mass spectrometry.
Measured: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start16 Feb 2022
- Primary completion27 Aug 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal TumorsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehraneh D Jafari, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136092
- Sponsor's protocol ID
- 21-03023487
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine Fructose Uptake by Primary Human Colorectal Tumors
- ClinicalTrials.gov ID
- NCT05136092
- Acronym / sponsor ID
- 21-03023487
- Conditions
- Colorectal Tumors
- Keywords
- Fructose, D-Xylose, Primary Human Colorectal Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: HFCS (fructose-fed) | Experimental | Dietary Supplement: Cohort 1: HFCS (fructose) fedOn 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 2: D-Xylose (xylose-fed) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1: HFCS (fructose) fedTwo 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 | Dietary supplement | Cohort 1: HFCS (fructose-fed) |
| 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 | Dietary supplement | Cohort 2: D-Xylose (xylose-fed) |
Primary outcome
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.
11 secondary outcomes
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)
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)
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)
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)
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 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 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 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 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 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 in the tumor
Time frame: Morning after the consumption of oral sugar solutions(during surgery at the time of specimen removal)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehraneh D Jafari, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohort 1: HFCS (fructose) fed and Cohort 2: D-Xylose (xylose-fed) in people with Colorectal Tumors, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.