Cancer Survivor, Colon Cancer, Colorectal Adenocarcinoma, Rectal Cancer, Stage I Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Conditions
Keywords
Resistant Starch, Colorectal Cancer
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.
Interventions
OTHERDietary Intervention (resistant starch)
Eat foods with resistant starch
OTHERDietary Intervention (regular starch)
Eat foods with regular corn starch
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, 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.
Intervention model description
Blinded, block randomization based on sex and BMI.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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\^2. * Uncontrolled constipation. * Inability to speak and fully understand English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Accrual | Up to 12 months | The accrual rate will be estimated with number of participants at full enrollment at 12 months. |
| Feasibility: Adherence | 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: Retention | 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
| Measure | Time frame | Description |
|---|---|---|
| Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin) | Baseline to follow-up at week 8 | Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics. |
| Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY | 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. |
| Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) | Baseline to follow-up at week 8 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-Active (Resistant Starch) 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. | 4 |
| 2-Control (Regular 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. | 6 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | 2-Control (Regular Starch) | Total | 1-Active (Resistant Starch) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 2 Participants |
| Age, Continuous | 50 years | 58.5 years | 62 years |
| BMI Category Normal weight | 3 Participants | 4 Participants | 1 Participants |
| BMI Category Obese I | 2 Participants | 3 Participants | 1 Participants |
| BMI Category Obese II+ | 1 Participants | 1 Participants | 0 Participants |
| BMI Category Overweight | 0 Participants | 2 Participants | 2 Participants |
| BMI Category Underweight | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index (BMI) | 27.2 kg/m^2 | 27.65 kg/m^2 | 27.7 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 173.75 cm | 176.00 cm | 177.54 cm |
| N-stage N0 | 2 Participants | 2 Participants | 0 Participants |
| N-stage N1 | 0 Participants | 1 Participants | 1 Participants |
| N-stage N1a | 1 Participants | 2 Participants | 1 Participants |
| N-stage N1b | 1 Participants | 1 Participants | 0 Participants |
| N-stage N1c | 2 Participants | 3 Participants | 1 Participants |
| N-stage N2 | 0 Participants | 1 Participants | 1 Participants |
| N-stage N2a | 0 Participants | 0 Participants | 0 Participants |
| N-stage N2b | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 4 Participants |
| Region of Enrollment United States | 6 participants | 10 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
| T-stage T0 | 0 Participants | 0 Participants | 0 Participants |
| T-stage T1 | 0 Participants | 0 Participants | 0 Participants |
| T-stage T2 | 1 Participants | 1 Participants | 0 Participants |
| T-stage T3 | 5 Participants | 8 Participants | 3 Participants |
| T-stage T4a | 0 Participants | 1 Participants | 1 Participants |
| T-stage T4b | 0 Participants | 0 Participants | 0 Participants |
| Weight | 88.95 kg | 85.90 kg | 85.88 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 2 / 3 | 4 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Feasibility: Accrual
The accrual rate will be estimated with number of participants at full enrollment at 12 months.
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1-Active (Resistant Starch) | Feasibility: Accrual | 4 Participants |
| 2-Control (Regular Starch) | Feasibility: Accrual | 5 Participants |
Primary
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.
Time frame: From start of intervention to ending intervention: up to 8 weeks
Population: Overall number of participants analyzed for the adherence measure: 7 (per protocol)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1-Active (Resistant Starch) | Feasibility: Adherence | 2 Participants |
| 2-Control (Regular Starch) | Feasibility: Adherence | 4 Participants |
Primary
Feasibility: Retention
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
Population: All participants enrolled, in accordance with protocol and Statistical Analysis Plan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1-Active (Resistant Starch) | Feasibility: Retention | 3 Participants |
| 2-Control (Regular Starch) | Feasibility: Retention | 5 Participants |
Secondary
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.
Time frame: Baseline to follow-up at week 8
Population: Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 followup timepoints on just 5 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-Active (Resistant Starch) | Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) | C-reactive protein - baseline | 1.24 mg/L | Standard Deviation 0.74 |
| 1-Active (Resistant Starch) | Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) | C-reactive protein - followup | 1.93 mg/L | Standard Deviation 2.37 |
| 2-Control (Regular Starch) | Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) | C-reactive protein - baseline | 1.98 mg/L | Standard Deviation 2.13 |
| 2-Control (Regular Starch) | Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) | C-reactive protein - followup | 1.67 mg/L | Standard Deviation 1.77 |
Secondary
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.
Time frame: Baseline to follow-up at weeks 2 and 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Alpha diversity - first follow-up (week 2) | 1376 Relative abundance | Standard Deviation 21.7 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Faecalibacterium Prausnitzii - second follow-up (week 8) | 0.98 Relative abundance | Standard Deviation 0.52 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Faecalibacterium Prausnitzii - baseline | 2.09 Relative abundance | Standard Deviation 1.31 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Akkermansia mucinipiila - baseline | 0.36 Relative abundance | Standard Deviation 0.22 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Alpha diversity - second follow-up (week 8) | 1288 Relative abundance | Standard Deviation 2.83 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Akkermansia mucinipiila - first follow-up (week 2) | 0.19 Relative abundance | Standard Deviation 0.05 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Faecalibacterium Prausnitzii - first follow-up (week 2) | 1.84 Relative abundance | Standard Deviation 1.02 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Akkermansia mucinipiila - second follow-up (week 8) | 0.19 Relative abundance | Standard Deviation 0.02 |
| 1-Active (Resistant Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Alpha diversity - baseline | 1344 Relative abundance | Standard Deviation 243.5 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Akkermansia mucinipiila - second follow-up (week 8) | 0.39 Relative abundance | Standard Deviation 0.48 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Alpha diversity - baseline | 1458 Relative abundance | Standard Deviation 265.2 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Alpha diversity - first follow-up (week 2) | 1111 Relative abundance | Standard Deviation 364 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Alpha diversity - second follow-up (week 8) | 1321 Relative abundance | Standard Deviation 75.4 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Faecalibacterium Prausnitzii - baseline | 2.62 Relative abundance | Standard Deviation 2.52 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Faecalibacterium Prausnitzii - first follow-up (week 2) | 1.77 Relative abundance | Standard Deviation 2.12 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Faecalibacterium Prausnitzii - second follow-up (week 8) | 2.09 Relative abundance | Standard Deviation 1.73 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Akkermansia mucinipiila - baseline | 0.35 Relative abundance | Standard Deviation 0.29 |
| 2-Control (Regular Starch) | Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA | Akkermansia mucinipiila - first follow-up (week 2) | 0.18 Relative abundance | Standard Deviation 0.11 |
Secondary
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.
Time frame: Baseline to followup at weeks 2 and 8
Population: Analysis limitation: due to low participant recruitment, there was insufficient number of stool samples available to detect and compute beta diversity.
Secondary
Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
Time frame: Baseline to follow-up at week 8
Population: Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 follow-up timepoints on just 5 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-Active (Resistant Starch) | Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin) | Adiponectin - baseline | 1.33 ug/mL | Standard Deviation 0.54 |
| 1-Active (Resistant Starch) | Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin) | Adiponectin - followup | 1.14 ug/mL | Standard Deviation 0.55 |
| 2-Control (Regular Starch) | Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin) | Adiponectin - baseline | 1.95 ug/mL | Standard Deviation 0.95 |
| 2-Control (Regular Starch) | Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin) | Adiponectin - followup | 2.08 ug/mL | Standard Deviation 1.11 |