Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors

Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study

This phase II, randomized pilot trial studies the effect of the consumption of foods made with resistant starch compared to foods made with corn starch on biomarkers that may be related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods made with resistant starch may beneficially influence markers of inflammation, insulin resistance, and the composition of gut bacteria in colorectal cancer survivors.

Participants are randomized to 1 of 2 groups.

GROUP I (INTERVENTION GROUP): Participants eat a diet consisting of resistant starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.

GROUP II (CONTROL GROUP): Participants eat a diet consisting of regular corn starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.

Inclusion Criteria:

• History of diagnosed American Joint Committee on Cancer (AJCC) stage I-III colorectal adenocarcinoma.
• Completed all treatment of colorectal adenocarcinoma within past 4-36 months.
• Current Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (per physician).
• Ability to consent and follow study protocol.

Exclusion Criteria:

• Active cancer.
• Prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin [Hgb] A1c > 8.0).
• Active inflammatory bowel disease (i.e., patients who are symptomatic despite medical therapy). This includes irritable bowel syndrome, Crohn's disease, or any other inflammatory bowel disorder.
• Known food allergy/intolerances to wheat, gluten, dairy or eggs.
• Use of antibiotic(s) within the last 3 months prior to enrollment.
• Women who are pregnant and/or breastfeeding.
• Current body mass index (BMI) < 18.5 kg/m^2.
• Uncontrolled constipation.
• Inability to speak and fully understand English.