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

Phase 2TerminatedNCT03781778

Fred Hutchinson Cancer Center10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Colon Cancer Rectal Cancer Cancer Survivor Colorectal Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Feasibility: Accrual

The accrual rate will be estimated with number of participants at full enrollment at 12 months.

Time frame: 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.

Time frame: 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.

Time frame: From start of intervention to the 8-week timepoint

Secondary Outcomes

Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)

Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to followup at weeks 2 and 8