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

Primary Purpose

Colon Cancer, Rectal Cancer, Cancer Survivor

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention (resistant starch)
Dietary Intervention (regular starch)
Questionnaire Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer focused on measuring Resistant Starch, Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (resistant starch foods)

Group II (foods with regular corn starch)

Arm Description

Patients eat a diet consisting of resistant starch foods daily for 8 weeks.

Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.

Outcomes

Primary Outcome Measures

Feasibility: Accrual
The accrual rate will be estimated with number of participants at full enrollment at 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.
Feasibility: Retention
The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.

Secondary Outcome Measures

Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
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.
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.
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.

Full Information

First Posted
December 14, 2018
Last Updated
September 9, 2022
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03781778
Brief Title
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
Official Title
Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to expiration of funding
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Resistant Starch, Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Blinded, block randomization based on sex and BMI.
Masking
ParticipantInvestigator
Masking Description
Assignment to the active versus control group will be blinded using a computer program and will be designated as "diet A" and "diet B". Investigators will be unblinded once the study and data analyses have been completed.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (resistant starch foods)
Arm Type
Experimental
Arm Description
Patients eat a diet consisting of resistant starch foods daily for 8 weeks.
Arm Title
Group II (foods with regular corn starch)
Arm Type
Active Comparator
Arm Description
Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention (resistant starch)
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Eat foods with resistant starch
Intervention Type
Other
Intervention Name(s)
Dietary Intervention (regular starch)
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Eat foods with regular corn starch
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility: Accrual
Description
The accrual rate will be estimated with number of participants at full enrollment at 12 months.
Time Frame
Up to 12 months
Title
Feasibility: Adherence
Description
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
Title
Feasibility: Retention
Description
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 Outcome Measure Information:
Title
Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
Description
Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
Time Frame
Baseline to follow-up at week 8
Title
Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)
Description
CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
Time Frame
Baseline to follow-up at week 8
Title
Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA
Description
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
Title
Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Neuhouser
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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