Dietary intervention to improve outcomes after colorectal cancer surgery
A Phase 1/2 Study of Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery (The DIET Trial)
This study tests if a special high-fiber, low-fat diet can help people with colorectal cancer have better outcomes after their surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06349590 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed colorectal adenocarcinoma scheduled for primary tumor resection.
Not a fit: Patients under 18 years of age or those with unique nutritional needs that cannot be met by the standardized diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of colorectal cancer recurrence and improve overall patient outcomes.
How similar studies have performed: While dietary interventions in cancer care are being explored, this specific approach of manipulating the gut microbiome through a standardized diet is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.