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

< Back to search results
This clinical trial matches:
Show Search Criteria
Status: Approved

Description

This phase II 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 II-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.

Eligibility Criteria

Inclusion Criteria

  • History of diagnosed American Joint Committee on Cancer (AJCC) stage II-III colorectal adenocarcinoma.
  • Completed all treatment of colorectal adenocarcinoma within past 6-24 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Ability to consent and follow study protocol.

Exclusion Criteria

  • No active cancer.
  • No prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin [Hgb] A1c > 8.0).
  • No active inflammatory bowel disease (i.e., patients who are symptomatic despite medical therapy).
  • No known food allergy/intolerances to wheat, gluten, dairy or eggs.
  • Women who are pregnant and/or breastfeeding are excluded.
  • Body mass index (BMI) < 18.5 kg/m^2.
  • No uncontrolled constipation.

Locations & Contacts

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Approved
Contact: Marian Louise Stone Neuhouser
Phone: 206-667-4797
Email: mneuhous@fredhutch.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility of an 8-week dietary intervention testing foods made with resistant starch compared to foods made with corn starch in patients who have completed treatment for stage II-III colorectal cancer.

SECONDARY OBJECTIVES:

I. To assess variability from baseline to 8 weeks in circulating markers of insulin resistance (glucose, insulin and homeostasis model of assessment-insulin resistance [HOMA-IR]) and inflammation (C-reactive protein [CRP], albumin, adiponectin), by randomization arm.

II. To assess variability from baseline to 2 weeks and 8 weeks in gut microbial communities based on 16S ribosomal ribonucleic acid (rRNA) gene sequencing, by randomization arm.

III. To explore whether resistant starch suppresses adenomas/carcinomas in human to mouse fecal microbiota transplantation (FMT) studies.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (ACTIVE GROUP): Participants eat a diet consisting of resistant starch foods daily for 8 weeks. Study 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 foods are in addition to their own usual daily diet.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Prevention

Lead Organization

Lead Organization
Fred Hutch / University of Washington Cancer Consortium

Principal Investigator
Marian Louise Stone Neuhouser

Trial IDs

Primary ID RG1003387
Secondary IDs NCI-2018-02802, 10079
Clinicaltrials.gov ID NCT03781778