Using a high fiber product to reduce chemotherapy-related diarrhea in colon cancer patients
A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery
This study is testing whether a high fiber product can help people with metastatic colon cancer reduce diarrhea caused by chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Hamilton, New Jersey and 9 other locations) |
| Trial ID | NCT05296681 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of NBT-NM108, a high dietary fiber formula, in reducing chemotherapy-induced diarrhea in patients with metastatic colon cancer undergoing treatment with irinotecan. The study aims to assess the dose intensity of irinotecan administered and the percentage of patients needing dose modifications due to diarrhea. Secondary endpoints include evaluating the toxicity grade of diarrhea, response rate, and progression-free survival. Additionally, exploratory endpoints will analyze changes in gut microbiota and markers of gut inflammation.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven metastatic colon cancer who are candidates for irinotecan-based chemotherapy and have a performance status of 0-1.
Not a fit: Patients experiencing grade two diarrhea or greater, or those currently on antibiotic therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for colon cancer patients by reducing diarrhea and enhancing their ability to tolerate chemotherapy.
How similar studies have performed: While the use of dietary interventions in chemotherapy is a growing area of interest, this specific approach with NBT-NM108 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Biopsy proven and metastatic colon cancer * Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w. Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseline consistency. * Performance Status (PS) 0-1 * Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) \>1500/uL; Creatinine \< 1.5 x Upper Limit of Normal (ULN); Transaminases \< 5x ULN; Bilirubin \< 1.5 x ULN; Albumin \> 3.0 g/dL * No known UGTA1A\* genotype Exclusion Criteria * Grade two diarrhea or greater (4-6 movements per day over baseline) * Inability to take oral supplements * Current antibiotic therapy * Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection. * History of the following infections and/or disease which could lead to diarrhea: * History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool. * History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.
Where this trial is running
Hamilton, New Jersey and 9 other locations
- Robert Wood Johnson University Hospital, Hamilton — Hamilton, New Jersey, United States (Recruiting)
- Monmouth Medical Center — Lakewood, New Jersey, United States (Recruiting)
- RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States (Recruiting)
- Cooperman Barnabas Medical Center — Livingston, New Jersey, United States (Recruiting)
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (Recruiting)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- The Cancer Center — Newark, New Jersey, United States (Recruiting)
- Newark Beth Israel Medical Center — Newark, New Jersey, United States (Recruiting)
- Robert Wood Johnson University Hospital, Somerset — Somerville, New Jersey, United States (Recruiting)
- Community Medical Center — Toms River, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Howard S Hochster, MD — Rutgers University
- Study coordinator: Howard S Hochster, MD
- Email: howard.hochster@rutgers.edu
- Phone: 732-235-2465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.