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

NCT03781778 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-06

Study results available
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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.

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

Interventions

OTHER

Dietary Intervention (resistant starch)

Eat foods with resistant starch

OTHER

Dietary Intervention (regular starch)

Eat foods with regular corn starch

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Marian Neuhouser · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781778 on ClinicalTrials.gov