← Back to Search

Anti-infective

Metronidazole for Rectal Cancer

Phase 2
Recruiting
Led By Michael G White, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with locally advanced rectal cancers (T3, T4, or N+ disease) with decision to treat with total neoadjuvant therapy
No previous cycles of cytotoxic chemotherapy in management of the index tumor
Must not have
Cockayne syndrome
Participants with uncontrolled intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

"This trial aims to see if adding metronidazole to the usual treatment can reduce the levels of harmful bacteria in patients with rectal cancer undergoing pre-surgery treatment, compared to those who only receive

Who is the study for?
This trial is for individuals with rectal adenocarcinoma who are about to receive neoadjuvant therapy. Participants should not have taken antibiotics recently and must be able to undergo standard cancer treatments.
What is being tested?
The study tests if metronidazole, an antibiotic, can reduce harmful bacteria in the gut when added to usual pre-surgery cancer treatment compared to the standard treatment alone.
What are the potential side effects?
Metronidazole may cause nausea, headaches, a metallic taste in the mouth, and rarely more serious effects like seizures or liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My rectal cancer is advanced but not yet treated with full pre-surgery therapy.
Select...
I haven't had chemotherapy for my current cancer.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
My heart function is classified as class 2B or better according to NYHA.
Select...
My blood counts and liver/kidney functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have Cockayne syndrome.
Select...
I do not have any uncontrolled illnesses.
Select...
I am currently taking disulfiram.
Select...
I have not had chemotherapy in the past year.
Select...
I have brain or other inoperable metastases and won't have standard rectal surgery.
Select...
I have not had chemotherapy or radiotherapy in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and adverse events (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care Neoadjuvant Therapy + MetronidazoleExperimental Treatment1 Intervention
Participants found to be eligible to take part in this study, will be randomly assigned (as in the flip of a coin) to receive standard therapy alone or standard therapy plus metronidazole. Participants are assigned to the metronidazole group, will also take 1 tablet of metronidazole by mouth every 8 hours for 2 weeks.
Group II: Standard of Care Neoadjuvant TherapyActive Control1 Intervention
Participants found to be eligible to take part in this study, will be randomly assigned (as in the flip of a coin) to receive standard therapy alone or standard therapy plus metronidazole. Participants in both study groups will receive their standard of care treatment, as assigned by their treating doctor outside of the research study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metronidazole
2011
Completed Phase 4
~3810

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,641 Total Patients Enrolled
Michael G White, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~0 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top