Pilot Trial of Resistant Starch in Stage II-III Colorectal Cancer Survivors
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | April 15, 2019 |
| End Date: | November 1, 2019 |
| Contact: | Marian Neuhouser |
| Email: | mneuhous@fredhutch.org |
| Phone: | 206-667-4797 |
Randomized, Controlled Trial of Resistant Starch in Stage II-III Colorectal Cancer Survivors Pilot Study
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.
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.
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.
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.
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.
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