Using a high fiber product to reduce chemotherapy-related diarrhea in colon cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.