Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Feasibility: Adherence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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^
- •Uncontrolled constipation.
- •Inability to speak and fully understand English.
Outcomes
Primary Outcomes
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.
Feasibility: Accrual
Time Frame: Up to 12 months
The accrual rate will be estimated with number of participants at full enrollment at 12 months.
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.
Secondary Outcomes
- 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)
Investigators
Marian Neuhouser
Professor
Fred Hutchinson Cancer Center