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TERMINATEDPHASE2

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

NCT03781778•Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

May 7, 2019

Primary Completion Date

October 1, 2020

Completion Date

October 1, 2020

Last Updated

October 6, 2022

Enrollment

ACTUAL participants

Conditions

Colon CancerRectal CancerCancer SurvivorColorectal AdenocarcinomaStage I Colorectal Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8

Interventions

Dietary Intervention (resistant starch)

OTHER

Dietary Intervention (regular starch)

OTHER

Questionnaire Administration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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