Solid Tumor
Conditions
Keywords
Immune checkpoint inhibitor
Brief summary
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.
Interventions
DRUGPotato starch
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).
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients starting dual immune checkpoint inhibitor therapy (ipilimumab and nivolumab in any dose combination) for solid cancer treatment per FDA approved indications. * Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* Patients with a history of colectomy and/or gastric bypass. * Patients with a known diagnosis of inflammatory bowel disease or irritable bowel syndrome. * Patients with active Clostridium difficile infection. Active infection is defined as a stool sample positive for Clostridium difficile toxin by EIA and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon. * Inability to take oral supplements * Patients with existing gastrointestinal symptoms including abdominal pain, diarrhea (watery stool), nausea and/or actively requiring regular anti-emetics. * Patients with symptomatic bowel metastasis including pain, severe constipation, or gastrointestinal bleeding. * Receiving antibiotic within 14 days of ICI therapy initiation. * Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients able to adhere to resistant starch (RS) supplement schedule | Approximately 13 weeks | 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. |
| Frequency of serious adverse events (SAEs) attributable to ICI therapy | Up to 6 months (3 months after RS supplement discontinuation) | 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. |
| Occurrence of unanticipated serious adverse events (SAEs) | Approximately 13 weeks | Adverse events will be assessed using the NCI CTCAE, version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of immunotherapy-induced diarrhea/colitis | Up to 6 months (3 months after RS supplement discontinuation) | Graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. |
| Change in luminal microbiome composition | Up to 6 months (3 months after RS supplement discontinuation) | 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. |
| Change in luminal microbiome metabolite | Up to 6 months (3 months after RS supplement discontinuation) | 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. |
Countries
United States
Outcome results
None listed