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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Cancer, Rectal Cancer, Cancer Survivor, Colorectal Adenocarcinoma, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8

Intervention / Treatment
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* Other: Dietary Intervention (resistant starch)
* Other: Dietary Intervention (regular starch)
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blinded, block randomization based on sex and BMI.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (resistant starch foods)<br>Patients eat a diet consisting of resistant starch foods daily for 8 weeks. | Other: Dietary Intervention (resistant starch)<br>* Eat foods with resistant starch<br>* Other names: Nutritional Interventions;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (foods with regular corn starch)<br>Patients eat a diet consisting of regular corn starch foods daily for 8 weeks. | Other: Dietary Intervention (regular starch)<br>* Eat foods with regular corn starch<br>* Other names: Nutritional Interventions;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Accrual | The accrual rate will be estimated with number of participants at full enrollment at 12 months. | Up to 12 months | 
| Feasibility: Adherence | 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. | From start of intervention to ending intervention: up to 8 weeks | 
| Feasibility: Retention | The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint. | From start of intervention to the 8-week timepoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin) | Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics. | Baseline to follow-up at week 8 | 
| Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) | CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics. | Baseline to follow-up at week 8 | 
| Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | 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. | Baseline to follow-up at weeks 2 and 8 | 
| Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY | 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. | Baseline to followup at weeks 2 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistant Starch, Colorectal Cancer