Clinical trial NCT03781778: Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
Official title: Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colon Cancer
Rectal Cancer
Cancer Survivor
Colorectal Adenocarcinoma
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
Keywords: Resistant Starch
Colorectal Cancer
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, block randomization based on sex and BMI.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Accrual
timeFrame: Up to 12 months
measure: Feasibility: Adherence
timeFrame: From start of intervention to ending intervention: up to 8 weeks
measure: Feasibility: Retention
timeFrame: From start of intervention to the 8-week timepoint
Secondary outcomes:
measure: Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
timeFrame: Baseline to follow-up at week 8
measure: Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)
timeFrame: Baseline to follow-up at week 8
measure: Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA
timeFrame: Baseline to follow-up at weeks 2 and 8
measure: Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY
timeFrame: Baseline to followup at weeks 2 and 8
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Marian Neuhouser
role: PRINCIPAL_INVESTIGATOR
References: