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Trial Title:
Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery
NCT ID:
NCT06349590
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Recurrence
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
High-fiber/low-fat meals
Description:
Meals with Low fat/High fiber
Arm group label:
Dietary Intervention Participants
Summary:
A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects
diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from
informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat
meals and complete a food diary up until lunch on the day prior to surgery. Blood samples
will be collected at baseline and on the day of surgery. Stool samples will be collected
throughout the dietary intervention period at specific timepoints, on the day of surgery,
and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid
cultures. Subjects will be followed per standard of care for up to 5 years or disease
recurrence, whichever comes first. Subject may be treated for their cancer prior to
surgery and/or during the follow-up period.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Must have histologically or cytologically confirmed colorectal adenocarcinoma.
- Planned for primary tumor resection at the University of Chicago Medicine ≥21 from
date of obtained informed consent. Patients with metastatic disease but undergoing
primary site resection are eligible for the study.
- Age ≥18 years.
- Patients <18 years of age, children are excluded from this study, because they have
unique nutritional requirements that might not be met by with the standardized diet.
The food in the diet is designed for adults and would not be feasible for children,
especially those attending school. In addition, colon cancer is extremely rare in
children.
- May have received neoadjuvant therapy (chemotherapy, radiation).
- Patients with Hepatic arterial infusion (HAI) pumps are considered eligible.
- Ability to understand and willing to sign an informed consent, participate in the
dietary intervention, collect stools, donate blood, and complete a pre-nutritional
evaluation and compliance/patient satisfaction survey.
Exclusion Criteria:
- Previous ostomy (ileostomy or colostomy) or definitive plan for an ostomy (ileostomy
or colostomy) during the procedure.
- Antibiotic exposure within 60 days before diet initiation. Antibiotic exposure is
defined as a 'course of treatment to treat an infection'. Prophylactic antibiotics
prior to a procedure is okay.
- Prebiotic/Probiotic exposure within 60 days before diet initiation.
- Concomitant separate malignancy.
- Allergy to perioperative medications (oral neomycin/metronidazole for bowel
preparation, intraoperative prophylactic intravenous cefazolin and metronidazole).
- Patients who are pregnant are not eligible for the study. Pregnant women are
excluded from this study because the preoperative diet is not specifically
formulated to meet the specific nutritional requirements during the prenatal period.
- History of inflammatory bowel disease
- Severe food allergies precluding the ability to tolerate the standardized dietary
intervention.
- Patients with uncontrolled intercurrent illness
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin Shogan, MD
Phone:
773-732-2260
Email:
bshogan@bsd.uchicago.edu
Contact backup:
Last name:
Leila Yazdanbakhsh
Phone:
773-834-6087
Email:
leila.yazdanbakhsh@bsd.uchicago.edu
Investigator:
Last name:
Benjamin Shogan, MD
Email:
Principal Investigator
Start date:
June 27, 2024
Completion date:
October 2029
Lead sponsor:
Agency:
University of Chicago
Agency class:
Other
Source:
University of Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06349590
