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

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ClinicalTrials.gov Identifier: NCT03781778
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Other: Dietary Intervention (resistant starch) Other: Dietary Intervention (regular starch) Other: Questionnaire Administration Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, block randomization based on sex and BMI.
Masking: Double (Participant, Investigator)
Masking Description: Assignment to the active versus control group will be blinded using a computer program and will be designated as "diet A" and "diet B". Investigators will be unblinded once the study and data analyses have been completed.
Primary Purpose: Prevention
Official Title: Randomized, Controlled Trial of Resistant Starch in Stage II-III Colorectal Cancer Survivors Pilot Study
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arm Intervention/treatment
Experimental: Group I (resistant starch foods)
Patients eat a diet consisting of resistant starch foods daily for 8 weeks.
Other: Dietary Intervention (resistant starch)
Eat foods with resistant starch
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group II (foods with regular corn starch)
Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.
Other: Dietary Intervention (regular starch)
Eat foods with regular corn starch
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Accrual Rate [ Time Frame: Up to 12 months ]
    The accrual rate will be estimated with a target accrual rate of full enrollment within 12 months after study activation.

  2. Interventional Adherence [ Time Frame: Baseline up to 8 weeks ]
    Adherence to the intervention will be defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks.

  3. Retention Rate [ Time Frame: At 8 weeks ]
    Target retention will be defined as >= 80% of participants providing blood and stool samples at 8 weeks.


Secondary Outcome Measures :
  1. Variability in biomarkers of insulin resistance [ Time Frame: Up to 8 weeks ]
    Will be assessed using descriptive statistics.

  2. Variability in biomarkers of inflammation [ Time Frame: Up to 8 weeks ]
    Will be assessed using descriptive statistics.

  3. Variability in gut microbial communities from human stool samples [ Time Frame: Up to 8 weeks ]
    Will use multivariate approach to assess significant changes in the microbiome in response to the intervention.

  4. Variability in gut microbial communities from human stool samples [ Time Frame: Up to 8 weeks ]
    Will use univariate approach to assess significant changes in the microbiome in response to the intervention.

  5. Fecal microbiota from resistant starch responders [ Time Frame: Up to 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781778


Contacts
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Contact: Marian Neuhouser 206-667-4797 mneuhous@fredhutch.org

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Marian Neuhouser    206-667-4797    mneuhous@fredhutch.org   
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Marian Neuhouser Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03781778     History of Changes
Other Study ID Numbers: RG1003387
NCI-2018-02802 ( Other Identifier: NCI / CTRP )
10079 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fred Hutchinson Cancer Research Center:
Resistant Starch
Colorectal Cancer
Recurrence

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases