Solid Tumor Clinical Trial
Official title:
Pilot Study of Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
Verified date | February 2024 |
Source | University of Michigan Rogel Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | January 24, 2023 |
Est. primary completion date | January 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Rogel Cancer Center | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Rogel Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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) | |
Primary | Occurrence of unanticipated serious adverse events (SAEs) | Adverse events will be assessed using the NCI CTCAE, version 5.0. | Approximately 13 weeks | |
Secondary | 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) | |
Secondary | 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. | Up to 6 months (3 months after RS supplement discontinuation) | |
Secondary | 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) |
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