Metronidazole as Preoperative Therapy in CRC / FusoMetro-001
ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncology Institute of Southern Switzerland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Metronidazole Oral
DrugMetronidazole will be administered per os at 500 mg x 3/day, for 10 days prior to surgery.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Metronidazole treated armExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 (+ 3) days after surgerySecondary outcomes
1
Potential effects of metronidazole on the expression of immune cell markers in CRC tissue samples
Expression of multiple immune cell markers will be assessed in tissue samples by immunohistochemistry and immunofluorescence. Number of positive cells/mm2 will be evaluated.
Time frame
12 (+ 3) days after surgery2
Potential effects of metronidazole on the expression of autophagy markers in CRC tissue samples
Expression of multiple autophagy signaling elements will be assessed in tissue samples by immunohistochemistry and immunofluorescence. Number of positive cells/mm2 will be evaluated.
Time frame
12 (+ 3) days after surgery3
Potential effects of metronidazole on microbiome
Differences in community diversity and/or abundance of specific bacterial taxa between the tumor-associated microbiome prior to or after antibiotic treatment.
Time frame
12 (+ 3) days after surgery4
Potential effects of metronidazole on the intestinal metabolic profile
Measurement of changes in the biosynthesis pathways of intestinal bacteria by comparing the gut metabolic profile before and after antibiotic treatment. Fold changes in the abundance of bacterial metabolites will be evaluated.
Time frame
12 (+ 3) days after surgerySponsors and contacts
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Source ClinicalTrials.gov