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NCT05296681 · ClinicalTrials.gov registry record · Phase 2
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
A Phase 2 study of Metastatic Colon Carcinoma and Stage IV Colon Cancer AJCC v8, sponsored by Howard S. Hochster, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 10
- Study locations
NCT05296681: Recruiting Phase 2 study of Metastatic Colon Carcinoma and Stage IV Colon Cancer AJCC v8, sponsored by Howard S. Hochster, MD.
NCT05296681 is a Phase 2 study of Metastatic Colon Carcinoma and Stage IV Colon Cancer AJCC v8 that is actively recruiting participants, run by Howard S. Hochster, MD. The registered enrollment target is 42 participants, below the 262-participant average among 3 other Metastatic Colon Carcinoma trials with a reported enrollment target (84% lower). The trial reports 10 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05296681, a Phase 2 study of Metastatic Colon Carcinoma and Stage IV Colon Cancer AJCC v8, is actively recruiting participants, sponsored by Howard S. Hochster, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
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. Dose reduction should occur for CTCAE grade 3 or higher toxicity given maximum antidiarrheal support with Imodium and/or Lomotil.
Conditions Studied
Interventions
- DRUG NBT-NM108
Study Locations (10)
New Jersey
- Robert Wood Johnson University Hospital, Hamilton - Hamilton
- Monmouth Medical Center - Lakewood
- RWJBarnabas Health - Monmouth Medical Center Southern Campus - Lakewood
- Cooperman Barnabas Medical Center - Livingston
- Robert Wood Johnson University Hospital - New Brunswick
- Rutgers Cancer Institute of New Jersey - New Brunswick
- The Cancer Center - Newark
- Newark Beth Israel Medical Center - Newark
- Robert Wood Johnson University Hospital, Somerset - Somerville
- Community Medical Center - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
What NCT05296681 shows while recruiting
NCT05296681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 262-participant average among 3 other Metastatic Colon Carcinoma trials with a reported enrollment target (84% lower).
The record links to 5 conditions, with Metastatic Colon Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which NBT-NM108 is the first listed.
NCT05296681 lists 10 locations in 1 state (New Jersey).
Frequently Asked Questions
What is clinical trial NCT05296681 about?
NCT05296681 is a clinical study titled "Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery". 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...
What is the current status of trial NCT05296681?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2022-05-03. Estimated completion is 2027-06-01.
What conditions does trial NCT05296681 study?
This clinical trial studies the following conditions: Metastatic Colon Carcinoma, Stage IV Colon Cancer AJCC v8, Stage IVA Colon Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8.
What interventions are being tested in trial NCT05296681?
The interventions under investigation include: NBT-NM108 (DRUG).
Who is sponsoring clinical trial NCT05296681?
This trial is sponsored by Howard S. Hochster, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05296681 being conducted?
This trial has 10 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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