Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
- Registration Number
- NCT04552418
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Potato-based dietary starch supplement Potato starch Patients undergoing cancer treatment with dual immune checkpoint inhibitors (ICI) will receive potato-based dietary starch supplements.
- Primary Outcome Measures
Name Time Method Occurrence of unanticipated serious adverse events (SAEs) 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 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 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 Outcome Measures
Name Time Method 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 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.
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.
Trial Locations
- Locations (1)
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States