Clinical trial · Interventional
Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to expiration of funding
Summary
Brief summary (as posted)
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
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Stage I Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIA Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIB Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention (regular starch) | Other | — | UNRESOLVED |
| Dietary Intervention (resistant starch) | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (resistant starch foods)
- description
- Patients eat a diet consisting of resistant starch foods daily for 8 weeks.
- interventionNames
- Other: Dietary Intervention (resistant starch)
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Group II (foods with regular corn starch)
- description
- Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.
- interventionNames
- Other: Dietary Intervention (regular starch)
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Feasibility: Accrual
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * History of diagnosed American Joint Committee on Cancer (AJCC) stage I-III colorectal adenocarcinoma. * 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: * Active cancer. * 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.
References
Publications (0)
Data not yet available