Metronidazole as Preoperative Therapy in CRC / FusoMetro-001

NCT05748145 | Recruiting Phase 2

• 1 other identifier: FusoMetro-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Impact of metronidazole on F.n. loads in CRC tissues.

  F.n. load assessed by qRT-PCR analysis in excised tumor tissues upon antibiotic treatment, as compared to corresponding diagnostic biopsies prior to treatment.

  12 (+ 3) days after surgery

Secondary Outcomes (4)

• Potential effects of metronidazole on the expression of immune cell markers in CRC tissue samples

  12 (+ 3) days after surgery

• Potential effects of metronidazole on the expression of autophagy markers in CRC tissue samples

  12 (+ 3) days after surgery

• Potential effects of metronidazole on microbiome

  12 (+ 3) days after surgery

• Potential effects of metronidazole on the intestinal metabolic profile

  12 (+ 3) days after surgery

Study Arms (1)

Metronidazole treated arm

EXPERIMENTAL

Administration of Metronidazole for 10 days prior to surgery in CRC patients

Drug: Metronidazole Oral

Interventions

Metronidazole Oral DRUG

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

Metronidazole treated arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent according to ICH/GCP regulations before registration.
• Age ≥ 18 years old
• Untreated, primary colorectal adenocarcinoma (\> 15 cm from the anal verge)
• Colonoscopy with endoscopic biopsy for disease confirmation and correlative studies.
• Candidates for surgical resection prior to administration of any therapy.

You may not qualify if:

• Insufficient material on the tissue biopsy to be left in the archives of the Cantonal Institute of Pathology for further evaluations/analyses
• Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives
• Oral or parenteral antibiotic therapy within the six weeks prior to enrolment
• Emergency surgery (planned within less than 14 days), where no opportunity to administer preoperative oral antibiotics exists
• Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervices uteri
• Any previous anticancer treatment prior resection
• Women who are pregnant or breast feeding
• Fertile women or men who do not use safe contraception during the study period
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
• Inability to consent and follow the procedures of the study e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment, affect patient compliance or place the patient at high risk from treatment-related complications

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead

Study Sites (1)

Oncology Institute of Southern Switzerland

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Sara De Dosso, MD

CONTACT

+41 91 811 93 02; sara.dedosso@eoc.ch

Luigi Tortola, PhD

CONTACT

+41 91 811 96 68; luigi.tortola@eoc.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of concept

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 28, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CH (1)