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.

Study Overview

• Status: Terminated
• Conditions: Rectal Cancer; Colon Cancer; Cancer Survivor; Colorectal Adenocarcinoma; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; 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
• Intervention / Treatment: Other: Questionnaire Administration; Other: Dietary Intervention (resistant starch); Other: Dietary Intervention (regular starch)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (resistant starch foods); Patients eat a diet consisting of resistant starch foods daily for 8 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Dietary Intervention (resistant starch); Eat foods with resistant starch; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions
Active Comparator: Group II (foods with regular corn starch); Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Dietary Intervention (regular starch); Eat foods with regular corn starch; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Marian Neuhouser, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Resistant Starch; Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: RG1003387; P30CA015704 (U.S. NIH Grant/Contract); 10079 (Fred Hutch/University of Washington Cancer Consortium); NCI-2018-02802 (Other Identifier: NCI / CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No