Microbiotic Product (NBT-NM108) to Reduce Chemotherapy-Induced Diarrhea

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial tests whether NBT-NM108 works in reducing chemotherapy-induced diarrhea in patients with colon cancer that has spread to other places in the body (metastatic). Irinotecan is one of the most used medicine for colon cancer, but it leads to diarrhea in most patients receiving it and among some of them, severe diarrhea can occur. NBT-NM108 is a high dietary fiber formula that is developed based on research findings that have shown that high fiber diets can help maintain healthy bacteria in the gut and improve gut function. Giving NBT-NM108 to patients with colon cancer receiving chemotherapy may help relieve or lessen diarrhea symptoms and lead to improved tolerance of the chemotherapy drug, irinotecan.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Howard S. Hochster, MD

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/m^2 every 2 weeks (q2w) Performance status (PS) 0-1 Absolute neutrophil count (ANC) >= 1500/uL Creatinine =< 1.5 X upper limit of normal (ULN) Transaminases =< 5 X ULN Bilirubin =< 1.5 x ULN Albumin >= 3.0 g/dL No known UGTA1A* genotype

Exclusion Criteria:

Grade 2 diarrhea or greater (4-6 movements per day over baseline) Inability to take oral supplements Current antibiotic therapy