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Potato starch for Solid Tumors

Phase < 1
Waitlist Available
Led By Leslie Fecher
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months (3 months after rs supplement discontinuation)
Awards & highlights

Study Summary

This trial will test if it's safe to give cancer patients a dietary supplement while also receiving treatment with two different types of immunotherapy drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months (3 months after rs supplement discontinuation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months (3 months after rs supplement discontinuation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of serious adverse events (SAEs) attributable to ICI therapy
Number of patients able to adhere to resistant starch (RS) supplement schedule
Occurrence of unanticipated serious adverse events (SAEs)
Secondary outcome measures
Change in luminal microbiome composition
Change in luminal microbiome metabolite
Incidence and severity of immunotherapy-induced diarrhea/colitis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Potato-based dietary starch supplementExperimental Treatment1 Intervention
Patients undergoing cancer treatment with dual immune checkpoint inhibitors (ICI) will receive potato-based dietary starch supplements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Potato starch
2023
Completed Early Phase 1
~50

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,085 Total Patients Enrolled
Leslie FecherPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Christopher Lao, MD, MPHPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
2021. "Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04552418.
~3 spots leftby Apr 2025
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