Study Stopped
Terminated due to expiration of funding
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
4 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedStudy Start
First participant enrolled
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedResults Posted
Study results publicly available
December 14, 2021
CompletedOctober 6, 2022
September 1, 2022
1.4 years
December 14, 2018
September 28, 2021
September 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
Baseline to follow-up at week 8
Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)
Baseline to follow-up at week 8
Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA
Baseline to follow-up at weeks 2 and 8
Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY
Baseline to followup at weeks 2 and 8
Study Arms (2)
Group I (resistant starch foods)
EXPERIMENTALPatients eat a diet consisting of resistant starch foods daily for 8 weeks.
Group II (foods with regular corn starch)
ACTIVE COMPARATORPatients eat a diet consisting of regular corn starch foods daily for 8 weeks.
Interventions
Eat foods with resistant starch
Eat foods with regular corn starch
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marian L. Neuhouser, PhD
- Organization
- Fred Hutchinson Cancer Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Marian Neuhouser
Fred Hutch/University of Washington Cancer Consortium
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 14, 2018
First Posted
December 20, 2018
Study Start
May 7, 2019
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
October 6, 2022
Results First Posted
December 14, 2021
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share