RecruitingPhase 2NCT05748145

Metronidazole as Preoperative Therapy in CRC / FusoMetro-001

Preoperative Treatment With Metronidazole to Evaluate the Efficacy in Reducing Fusobacterium Nucleatum Tumor Colonization in Patients With Colorectal Cancer (CRC): a Proof-of-concept Trial


Sponsor

Oncology Institute of Southern Switzerland

Enrollment

40 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The proposed proof-of concept trial aims at determining the effectiveness of metronidazole in decreasing the Fusobacterium nucleatum load in tissues and possibly on its detrimental effects on tumor cells and tumor microenvironment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking the antibiotic metronidazole before surgery can improve outcomes for people with colon cancer whose tumors contain a specific bacteria called Fusobacterium nucleatum, which has been linked to worse survival in colorectal cancer. **You may be eligible if...** - You are 18 or older - You have a newly diagnosed primary colorectal cancer that is more than 15 cm from the anal opening - You are a candidate for surgical removal of the tumor - You have not received any prior treatment for this cancer **You may NOT be eligible if...** - You have a known allergy to metronidazole or similar antibiotics - You have taken antibiotics in the 6 weeks before enrollment - You need emergency surgery (within 14 days) - You have had another cancer in the past 5 years (except minor skin cancers or cervical carcinoma in situ) - You are pregnant or breastfeeding - You have significant kidney, liver, or cardiovascular disease 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 Oral

Metronidazole will be administered per os at 500 mg x 3/day, for 10 days prior to surgery.


Locations(1)

Oncology Institute of Southern Switzerland

Bellinzona, Canton Ticino, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05748145


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