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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
Must not have
Current antibiotic therapy
Grade two diarrhea or greater (4-6 movements per day over baseline)
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
No Placebo-Only Group
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.
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.
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 belowSelect...
I am eligible for a second or later round of chemotherapy that includes irinotecan.
Select...
I don't know my UGTA1A* genotype.
Select...
I can carry out all my usual activities without help.
Select...
My colon cancer has spread and was confirmed by a biopsy.
Select...
I stopped taking irinotecan over 3 months ago and my bowel movements are normal again.
Select...
I am eligible for a specific chemotherapy treatment as my next step.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking antibiotics.
Select...
I experience diarrhea with 4-6 more bowel movements daily than usual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ eight weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eight weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Side effects data
From 2022 Phase 2 trial • 42 Patients • NCT0454040619%
Mild adverse events
100%
80%
60%
40%
20%
0%
Study treatment Arm
NBT-NM108 + Usual Care
Usual Care Only
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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
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