Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Start Date
5/3/2022
Completion Date
6/1/2027
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.
Detailed Description
PRIMARY ENDPOINT: Dose Intensity of Irinotecan administered (mg/m2/week) SECONDARY ENDPOINTS: 1. Reduction in % Patients Needing Dose Modification for Diarrhea 2. Toxicity Grade of diarrhea 3. Response Rate 4. Time to Progression-free survival EXPLORATORY ENDPOINTS: 1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome 2. Short chain fatty acids analysis (promotion of acetic and butyric acid production) 3. Markers for gut inflammation such as fecal lipocalin 2 4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
NBT-NM108
Conditions
Locations
Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey 08690
United States
Monmouth Medical Center
Lakewood, New Jersey 08701
United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey 08701
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey 07039
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
The Cancer Center
Newark, New Jersey 07103
United States
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United States
Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey 08876
United States
Community Medical Center
Toms River, New Jersey 08753
United States