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

September 9, 2022 updated by: Marian Neuhouser, Fred Hutchinson Cancer Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 12 months
The accrual rate will be estimated with number of participants at full enrollment at 12 months.
Up to 12 months
Feasibility: Adherence
Time Frame: 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.
From start of intervention to ending intervention: up to 8 weeks
Feasibility: Retention
Time Frame: 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.
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)
Time Frame: Baseline to follow-up at week 8
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)
Time Frame: Baseline to follow-up at week 8
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
Time Frame: 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.
Baseline to follow-up at weeks 2 and 8
Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY
Time Frame: 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.
Baseline to followup at weeks 2 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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