Pilot Study of Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
Overview
- Phase
- Early Phase 1
- Intervention
- Potato starch
- Conditions
- Solid Tumor
- Sponsor
- University of Michigan Rogel Cancer Center
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Occurrence of unanticipated serious adverse events (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Potato-based dietary starch supplement
Patients undergoing cancer treatment with dual immune checkpoint inhibitors (ICI) will receive potato-based dietary starch supplements.
Intervention: Potato starch
Outcomes
Primary Outcomes
Occurrence of unanticipated serious adverse events (SAEs)
Time Frame: Approximately 13 weeks
Adverse events will be assessed using the NCI CTCAE, version 5.0.
Frequency of serious adverse events (SAEs) attributable to ICI therapy
Time Frame: 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.
Number of patients able to adhere to resistant starch (RS) supplement schedule
Time Frame: 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.
Secondary Outcomes
- Incidence and severity of immunotherapy-induced diarrhea/colitis(Up to 6 months (3 months after RS supplement discontinuation))
- Change in luminal microbiome metabolite(Up to 6 months (3 months after RS supplement discontinuation))
- Change in luminal microbiome composition(Up to 6 months (3 months after RS supplement discontinuation))