Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
NCT ID: NCT03781778
Last Updated: 2022-10-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2019-05-07
2020-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group I (resistant starch foods)
Patients eat a diet consisting of resistant starch foods daily for 8 weeks.
Dietary Intervention (resistant starch)
Eat foods with resistant starch
Questionnaire Administration
Ancillary studies
Group II (foods with regular corn starch)
Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.
Dietary Intervention (regular starch)
Eat foods with regular corn starch
Questionnaire Administration
Ancillary studies
Interventions
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Dietary Intervention (resistant starch)
Eat foods with resistant starch
Dietary Intervention (regular starch)
Eat foods with regular corn starch
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Marian Neuhouser
Professor
Principal Investigators
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Marian Neuhouser
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2018-02802
Identifier Type: OTHER
Identifier Source: secondary_id
10079
Identifier Type: OTHER
Identifier Source: secondary_id
RG1003387
Identifier Type: -
Identifier Source: org_study_id
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