Trial Outcomes & Findings for Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors (NCT NCT03781778)
NCT ID: NCT03781778
Last Updated: 2022-10-06
Results Overview
The accrual rate will be estimated with number of participants at full enrollment at 12 months.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2022-10-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
Started Intervention
|
3
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
Baseline characteristics by cohort
| Measure |
1-Active (Resistant Starch)
n=4 Participants
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.
|
2-Control (Regular Starch)
n=6 Participants
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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
50 years
n=7 Participants
|
58.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Height
|
177.54 cm
n=5 Participants
|
173.75 cm
n=7 Participants
|
176.00 cm
n=5 Participants
|
|
Weight
|
85.88 kg
n=5 Participants
|
88.95 kg
n=7 Participants
|
85.90 kg
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.7 kg/m^2
n=5 Participants
|
27.2 kg/m^2
n=7 Participants
|
27.65 kg/m^2
n=5 Participants
|
|
BMI Category
Underweight
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI Category
Normal weight
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
BMI Category
Overweight
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI Category
Obese I
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
BMI Category
Obese II+
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
T-stage
T0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
T-stage
T1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
T-stage
T2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
T-stage
T3
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
T-stage
T4a
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
T-stage
T4b
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
N-stage
N0
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
N-stage
N1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
N-stage
N1a
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
N-stage
N1b
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
N-stage
N1c
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
N-stage
N2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
N-stage
N2a
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
N-stage
N2b
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsThe accrual rate will be estimated with number of participants at full enrollment at 12 months.
Outcome measures
| Measure |
1-Active (Resistant Starch)
n=4 Participants
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.
|
2-Control (Regular Starch)
n=5 Participants
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.
|
|---|---|---|
|
Feasibility: Accrual
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From start of intervention to ending intervention: up to 8 weeksPopulation: Overall number of participants analyzed for the adherence measure: 7 (per protocol)
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.
Outcome measures
| Measure |
1-Active (Resistant Starch)
n=3 Participants
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.
|
2-Control (Regular Starch)
n=4 Participants
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.
|
|---|---|---|
|
Feasibility: Adherence
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From start of intervention to the 8-week timepointPopulation: All participants enrolled, in accordance with protocol and Statistical Analysis Plan
The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.
Outcome measures
| Measure |
1-Active (Resistant Starch)
n=4 Participants
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.
|
2-Control (Regular Starch)
n=6 Participants
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.
|
|---|---|---|
|
Feasibility: Retention
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to follow-up at week 8Population: Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 follow-up timepoints on just 5 participants.
Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
Outcome measures
| Measure |
1-Active (Resistant Starch)
n=2 Participants
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.
|
2-Control (Regular Starch)
n=3 Participants
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.
|
|---|---|---|
|
Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
Adiponectin - baseline
|
1.33 ug/mL
Standard Deviation 0.54
|
1.95 ug/mL
Standard Deviation 0.95
|
|
Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
Adiponectin - followup
|
1.14 ug/mL
Standard Deviation 0.55
|
2.08 ug/mL
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline to follow-up at week 8Population: Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 followup timepoints on just 5 participants.
CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
Outcome measures
| Measure |
1-Active (Resistant Starch)
n=2 Participants
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.
|
2-Control (Regular Starch)
n=3 Participants
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.
|
|---|---|---|
|
Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)
C-reactive protein - baseline
|
1.24 mg/L
Standard Deviation 0.74
|
1.98 mg/L
Standard Deviation 2.13
|
|
Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)
C-reactive protein - followup
|
1.93 mg/L
Standard Deviation 2.37
|
1.67 mg/L
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Baseline to follow-up at weeks 2 and 8Population: 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.
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.
Outcome measures
| Measure |
1-Active (Resistant Starch)
n=3 Participants
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.
|
2-Control (Regular Starch)
n=4 Participants
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.
|
|---|---|---|
|
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
|
1.77 Relative abundance
Standard Deviation 2.12
|
|
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
|
2.09 Relative abundance
Standard Deviation 1.73
|
|
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
|
0.18 Relative abundance
Standard Deviation 0.11
|
|
Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA
Alpha diversity - baseline
|
1344 Relative abundance
Standard Deviation 243.50
|
1458 Relative abundance
Standard Deviation 265.20
|
|
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 21.70
|
1111 Relative abundance
Standard Deviation 364.00
|
|
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
|
1321 Relative abundance
Standard Deviation 75.40
|
|
Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA
Faecalibacterium Prausnitzii - baseline
|
2.09 Relative abundance
Standard Deviation 1.31
|
2.62 Relative abundance
Standard Deviation 2.52
|
|
Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA
Akkermansia mucinipiila - baseline
|
0.36 Relative abundance
Standard Deviation 0.22
|
0.35 Relative abundance
Standard Deviation 0.29
|
|
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
|
0.39 Relative abundance
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline to followup at weeks 2 and 8Population: Analysis limitation: due to low participant recruitment, there was insufficient number of stool samples available to detect and compute 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.
Outcome measures
Outcome data not reported
Adverse Events
1-Active (Resistant Starch)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2-Control (Regular Starch)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1-Active (Resistant Starch)
n=3 participants at risk
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.
|
2-Control (Regular Starch)
n=4 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Gassiness
|
66.7%
2/3 • Number of events 2 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
100.0%
4/4 • Number of events 4 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 1 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
75.0%
3/4 • Number of events 3 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
|
Gastrointestinal disorders
Increased frequency of bowel movements
|
33.3%
1/3 • Number of events 1 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
50.0%
2/4 • Number of events 2 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
|
Gastrointestinal disorders
Heartburn
|
33.3%
1/3 • Number of events 1 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
0.00%
0/4 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
25.0%
1/4 • Number of events 1 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
|
Gastrointestinal disorders
Loose stool
|
0.00%
0/3 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
50.0%
2/4 • Number of events 2 • From start of intervention to ending the intervention: up to 8 weeks.
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.
|
Additional Information
Marian L. Neuhouser, PhD
Fred Hutchinson Cancer Research Center
Phone: 2066674797
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place