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Digestive System Neoplasms

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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.

Dietary Intervention (resistant starch)

Dietary Intervention (regular starch)

Questionnaire Administration

Marian Neuhouser

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.

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.

Blinded, block randomization based on sex and BMI.

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.

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

The accrual rate will be estimated with number of participants at full enrollment at 12 months.

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.

The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.

Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.

CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.

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.

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.

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Professor

Method of assessment: weekly participant-completed questionnaire. The number of participants (n=7) analyzed for adverse events ("number at risk" below) is fewer than the number enrolled (n=10) because 3 participants withdrew consent prior to starting the intervention.

Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.

1-Active (Resistant Starch)

Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.

2-Control (Regular Starch)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

BMI Category

Participants were staged clinically by the interdisciplinary clinical oncology team per American Joint Committee on Cancer Staging Criteria for colorectal carcinoma (AJCC 8th edition). AJCC Stage Groupings I-III for colorectal carcinoma were eligible for the trial. Prognostic outcomes are considered better for lower stages and worse for higher stages.

T-stage

N-stage

Marian L. Neuhouser, PhD

Feasibility: Accrual

Overall number of participants analyzed for the adherence measure: 7 (per protocol)

Feasibility: Adherence

All participants enrolled, in accordance with protocol and Statistical Analysis Plan

Feasibility: Retention

Adiponectin - baseline

Adiponectin - followup

Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 follow-up timepoints on just 5 participants.

Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)

C-reactive protein - baseline

C-reactive protein - followup

Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 followup timepoints on just 5 participants.

Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)

Alpha diversity - baseline

Alpha diversity - first follow-up (week 2)

Alpha diversity - second follow-up (week 8)

Faecalibacterium Prausnitzii - baseline

Faecalibacterium Prausnitzii - first follow-up (week 2)

Faecalibacterium Prausnitzii - second follow-up (week 8)

Akkermansia mucinipiila - baseline

Akkermansia mucinipiila - first follow-up (week 2)

Akkermansia mucinipiila - second follow-up (week 8)

Of the 10 participants enrolled to this study, fecal samples were collected at baseline and followup for 7 participants. Of these 7 participants, one participant on Arm 1 dropped out of the study after week 2 hence the week 8 followup fecal was not obtained. For the remaining 6 participants, fecal samples from all three time-points were analyzed.

Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA

Analysis limitation: due to low participant recruitment, there was insufficient number of stool samples available to detect and compute beta diversity.

Spots Global Cancer Trial Database for dietary intervention (regular starch)