Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HUM00178229 | Other Identifier | University of Michigan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot study designed to assess the safety and feasibility of administering a dietary supplement to patients undergoing cancer treatment with a dual immune checkpoint inhibitors (ICIs) for solid cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potato-based dietary starch supplement | Experimental | Patients undergoing cancer treatment with dual immune checkpoint inhibitors (ICI) will receive potato-based dietary starch supplements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potato starch | Drug | Starting 5-7 days before treatment with dual-ICI, participant will consume 20g of potato starch (Bob's Red Mill®) once a day for 3 days, then increase to 20g twice a day, continuing throughout dual-ICI treatment (total duration approximately 13 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients able to adhere to resistant starch (RS) supplement schedule | Feasibility will be determined by calculating the number of patients who have taken 70% or more of scheduled dose of dietary intervention. Patients will be asked to record doses of starch taken and will be provided a table in which doses can be checked off. | Approximately 13 weeks |
| Frequency of serious adverse events (SAEs) attributable to ICI therapy | Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency of known serious effects of ICIs will be compared to historical rates. | Up to 6 months (3 months after RS supplement discontinuation) |
| Occurrence of unanticipated serious adverse events (SAEs) | Adverse events will be assessed using the NCI CTCAE, version 5.0. | Approximately 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of immunotherapy-induced diarrhea/colitis | Graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | Up to 6 months (3 months after RS supplement discontinuation) |
| Change in luminal microbiome composition |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leslie Fecher | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Weekly stool samples will be compared to the baseline sample (prior to starting starch-based dietary supplement). Stool samples will be analyzed for microbial nucleic acids to characterize the components of the stool microbiome. |
| Up to 6 months (3 months after RS supplement discontinuation) |
| Change in luminal microbiome metabolite | Weekly stool samples will be compared to the baseline sample (prior to starting starch-based dietary supplement). Key metabolic byproducts will be identified in stool specimens using liquid chromatography and mass spectrometry. | Up to 6 months (3 months after RS supplement discontinuation) |
| Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |