Dietary intervention to improve outcomes after colorectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of a standardized high-fiber, low-fat diet on patients diagnosed with colorectal cancer who are scheduled for tumor resection. Participants will follow this dietary regimen for 21 days prior to surgery, during which they will maintain a food diary and provide stool and blood samples at specified intervals. The goal is to assess how manipulating the gut microbiome through diet may prevent cancer recurrence and metastasis post-surgery. Patients will be monitored for up to five years or until disease recurrence.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Benjamin Shogan — University of Chicago
• Study coordinator: Benjamin Shogan, MD
• Email: bshogan@bsd.uchicago.edu
• Phone: 773-732-2260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.