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

Phase 2

Terminated

Conditions: Stage IIIC Colorectal Cancer AJCC v8
Rectal Cancer
Stage IIB Colorectal Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Colon Cancer
Cancer Survivor
Colorectal Adenocarcinoma
Stage I Colorectal Cancer AJCC v8
Stage II Colorectal Cancer AJCC v8
Stage IIA Colorectal Cancer AJCC v8

Interventions: Other: Dietary Intervention (resistant starch)
Other: Dietary Intervention (regular starch)
Other: Questionnaire Administration

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Group II (foods with regular corn starch)	Questionnaire Administration	Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.
Group I (resistant starch foods)	Dietary Intervention (resistant starch)	Patients eat a diet consisting of resistant starch foods daily for 8 weeks.
Group II (foods with regular corn starch)	Dietary Intervention (regular starch)	Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.
Group I (resistant starch foods)	Questionnaire Administration	Patients eat a diet consisting of resistant starch foods daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Feasibility: Adherence	From start of intervention to ending intervention: up to 8 weeks	The adherence endpoint pertains to adherence to the intervention and is defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks.
Feasibility: Accrual	Up to 12 months	The accrual rate will be estimated with number of participants at full enrollment at 12 months.
Feasibility: Retention	From start of intervention to the 8-week timepoint	The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.

Secondary Outcome Measures

Name	Time	Method
Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)	Baseline to follow-up at week 8	Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)	Baseline to follow-up at week 8	CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA	Baseline to follow-up at weeks 2 and 8	This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in alpha diversity and genera in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes int he microbiome in response to the intervention.
Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY	Baseline to followup at weeks 2 and 8	This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in global microbial community (beta diversity) in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes in the microbiome in response to the intervention.