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High Dietary Fiber Formula for Colon Cancer

Phase 2

Recruiting

Led By Howard Hochster, MD

Research Sponsored by Howard S. Hochster, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w

No known UGTA1A* genotype

Timeline

Screening 3 weeks

Treatment Varies

Follow Up imaging for response assessment will be obtained before the initiation of conditioning (no more than 4 weeks prior to apheresis) and at the 6-week follow up time point

Awards & highlights

Study Summary

This trial is testing whether a high dietary fiber formula can reduce chemotherapy-induced diarrhea in patients with metastatic colon cancer.

Who is the study for?

This trial is for adults with metastatic colon cancer who are set to receive irinotecan-based chemotherapy. They must have a good performance status, meaning they're able to carry out daily activities with little or no assistance. Their blood counts and organ functions need to meet specific criteria, and they shouldn't have had irinotecan or severe diarrhea recently.Check my eligibility

What is being tested?

The trial is testing NBT-NM108, a high dietary fiber formula designed to reduce chemotherapy-induced diarrhea by supporting gut bacteria health. It aims to improve patients' tolerance of the chemo drug irinotecan, which often causes diarrhea in those treated for advanced colon cancer.See study design

What are the potential side effects?

While the side effects of NBT-NM108 aren't detailed here, it's generally expected that high fiber supplements could cause bloating, gas or changes in bowel habits as your body adjusts. The main focus is on reducing severe side effects from chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a second or later round of chemotherapy that includes irinotecan.

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I don't know my UGTA1A* genotype.

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I can carry out all my usual activities without help.

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My colon cancer has spread and was confirmed by a biopsy.

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I stopped taking irinotecan over 3 months ago and my bowel movements are normal again.

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I am eligible for a specific chemotherapy treatment as my next step.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ eight weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~eight weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and eight weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting

Tumor Response by RECIST v1.1 Criteria

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NM108 DrinksExperimental Treatment1 Intervention

NBT-NM108 Drinks four times daily before meals and 2 hours after dinner for 56 days. Beginning 5 days before starting chemotherapy, patients receive NBT-NM108 PO QID for 56 days. Patients receive irinotecan-based chemotherapy per standard of care.

Group II: No Microbiome SupportActive Control1 Intervention

No microbiome Patients receive irinotecan-based chemotherapy per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBT-NM108

2023

Completed Phase 2

~60

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Howard S. Hochster, MDLead Sponsor

Howard Hochster, MDPrincipal InvestigatorRutgers University

2 Previous Clinical Trials

59 Total Patients Enrolled

Howard S Hochster, MDPrincipal InvestigatorRutgers University

1 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is NBT-NM108 a danger to human health?

"While there is some evidence that NBT-NM108 is safe, as this is only a Phase 2 trial, the lack of data regarding efficacy gives it a safety score of 2."

Answered by AI

Is this clinical trial taking place at several locations within the state?

"There are presently 10 sites where this study is being conducted. The locations are based in Elizabeth, Newark and Somerville along with other locations 10 other locations. If you participate in this trial, it is important to select the clinic closest to your residence to minimize travel requirements."

Answered by AI

Are there any vacancies in this research project for participants?

"Based on the information available from clinicaltrials.gov, it does appear that this trial is still looking for participants. The study was initially posted on May 3rd, 2022 and was edited as recently as October 17th of the same year. There are currently 10 active recruiting sites and the goal is to have 42 patients total enrolled in the trial."

Answered by AI

How many people are being included in this trial?

"The clinical trial is currently looking for participants, with the most recent edit on 10/17/2022. The study was originally posted on 5/3/2022 and is searching for 42 patients between 10 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Howard S. Hochster, MD 2022. "Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05296681.

All > Colon Cancer > Microbiome