Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors

NCT04552418 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: UMCC 2020.010HUM00178229
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• Occurrence of unanticipated serious adverse events (SAEs)

  Adverse events will be assessed using the NCI CTCAE, version 5.0.

  Approximately 13 weeks

Secondary Outcomes (3)

• Incidence and severity of immunotherapy-induced diarrhea/colitis

  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)

• Change in luminal microbiome metabolite

  Up to 6 months (3 months after RS supplement discontinuation)

Study Arms (1)

Potato-based dietary starch supplement

EXPERIMENTAL

Patients undergoing cancer treatment with dual immune checkpoint inhibitors (ICI) will receive potato-based dietary starch supplements.

Drug: Potato starch

Interventions

Potato starch DRUG

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).

Also known as: Resistant starch

Potato-based dietary starch supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Resistant Starch

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Leslie Fecher

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: June 2, 2021
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)