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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
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).
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 13 weeks
Incidence and severity of immunotherapy-induced diarrhea/colitis
Graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: Up to 6 months (3 months after RS supplement discontinuation)
Change in luminal microbiome composition
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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 6 months (3 months after RS supplement discontinuation)