RecruitingPhase 2NCT06569368

Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy

A Phase II Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy


Sponsor

M.D. Anderson Cancer Center

Enrollment

60 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To learn if adding metronidazole to standard therapy can decrease populations of Fusobacterium nucleatum (F. nucleatum) and other anaerobes (small organisms that cause infections) in participants with rectal cancer receiving neoadjuvant therapy, compared to neoadjuvant therapy alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an antibiotic called metronidazole to standard treatment for locally advanced rectal cancer changes the gut microbiome (the community of bacteria in the bowel) in a way that could improve how the cancer responds to treatment. Researchers believe certain gut bacteria may affect how well chemotherapy and radiation work. **You may be eligible if:** - You are 18 or older with locally advanced rectal cancer (T3, T4, or spread to lymph nodes) - You are being treated with total neoadjuvant therapy (chemotherapy and radiation before surgery) - You have not received chemotherapy for this cancer before - You are in good general health (ECOG score 2 or lower) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if:** - You have already received chemotherapy for this cancer - You are under 18 years old - You have uncontrolled hepatitis B or other significant health conditions - Your organ function does not meet minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetronidazole

Given by PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06569368


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