Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors

Rectal Cancer Clinical Trial

Official title:

Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03781778
• Other study ID #: RG1003387
• Secondary ID: NCI-2018-0280210
• Status: Terminated
• Phase: Phase 2
• Start date: May 7, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2022
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Survivor
• Colon Cancer
• Colorectal Adenocarcinoma
• Colorectal Neoplasms
• Rectal Cancer
• Stage I Colorectal Cancer AJCC v8
• Stage II Colorectal Cancer AJCC v8
• Stage IIA Colorectal Cancer AJCC v8
• Stage IIB Colorectal Cancer AJCC v8
• Stage IIC Colorectal Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage IIIA Colorectal Cancer AJCC v8
• Stage IIIB Colorectal Cancer AJCC v8
• Stage IIIC Colorectal Cancer AJCC v8

Intervention

Other:
• Dietary Intervention (resistant starch)
Eat foods with resistant starch
• Dietary Intervention (regular starch)
Eat foods with regular corn starch
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Accrual	The accrual rate will be estimated with number of participants at full enrollment at 12 months.	Up to 12 months
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.	From start of intervention to ending intervention: up to 8 weeks
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.	From start of intervention to the 8-week timepoint
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.	Baseline to follow-up at week 8
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.	Baseline to follow-up at week 8
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.	Baseline to follow-up at weeks 2 and 8
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.	Baseline to followup at weeks 2 and 8