A Standardized Diet before Colorectal Cancer Surgery for the Prevention of Colorectal Cancer Recurrence and Metastasis after Surgery in Patients with Colorectal Cancer, The DIET Trial

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This phase I/II trial tests the safety and how well a standardized diet before colorectal cancer (CRC) surgery works in preventing CRC recurrence and metastasis after surgery in patients with CRC. A standardized low-fat/high-fiber diet before CRC surgery may prevent CRC that has come back after a period of improvement (recurrence) and CRC that has spread from where it first started (primary site) to other places in the body (metastasis) after surgery in patients with CRC. The effects of diet and nutrition on gut bacteria may cause CRC to come back after surgery. Gut bacteria can cause tumor cells to shed. Certain gut/stomach bacteria (also known as the “microbiome”) can carry tumor-causing cells from one tumor to other healthy tissue in the body despite having the tumor surgically removed. A diet that is high in saturated fat and low in dietary fiber is a risk factor for both CRC and CRC recurrence. A standardized low-fat/high-fiber diet may slow or stop the formation of these cancer-causing bacteria by limiting the fatty foods they need. Eating a standardized low-fat/high-fiber diet before CRC surgery may be safe and effective in preventing CRC recurrence and metastasis after surgery in patients with CRC.

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 artery 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 that is undergoing treatment.
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.

PRIMARY OBJECTIVE:

I. To determine the effect of the dietary intervention on the collagenolytic potential of the microenvironment.

SECONDARY OBJECTIVE:

I. To determine the effect of the dietary intervention on other aspects of the gut microenvironment such as: components of the urokinase plasminogen activator (uPA)-plasminogen system, the composition and function of the gut microbiome (metagenomics), and concentrations of short-chain fatty acids and bile acids.

TERTIARY OBJECTIVE:

I. To determine if the dietary intervention decreases the incidence of postoperative CRC recurrence compared to historical controls.

OUTLINE:

Patients receive a standardized low-fat/high-fiber diet orally (PO) for 3 meals per day for 21 days before surgery and end at lunch on the day prior to surgery. The diet continues for 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo standard of care surgery and tissue sample collection on study as well as stool and blood sample collection throughout the study.

After completion of study intervention, patients are followed up to 5 years.

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A Standardized Diet before Colorectal Cancer Surgery for the Prevention of Colorectal Cancer Recurrence and Metastasis after Surgery in Patients with Colorectal Cancer, The DIET Trial

Inclusion Criteria

Exclusion Criteria

United States

Illinois

Chicago

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A Standardized Diet before Colorectal Cancer Surgery for the Prevention of Colorectal Cancer Recurrence and Metastasis after Surgery in Patients with Colorectal Cancer, The DIET Trial

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