Phase II Study on Using Metronidazole to Improve Gut Health in Rectal Cancer Patients Receiving Pre-Surgery Treatment

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06569368

Provider View

This clinical trial is exploring whether adding the antibiotic metronidazole to standard pre-surgery treatment can reduce certain bacteria in the gut of patients with rectal cancer, potentially improving treatment outcomes.

Patient Parameters

Program Overview

The aim of this study is to see if adding metronidazole to the usual treatment for rectal cancer can lower the levels of certain bacteria, like Fusobacterium nucleatum, in patients undergoing pre-surgery therapy. Researchers want to find out if this approach can help control the cancer better than the standard treatment alone.

Description

The main goal of this study is to measure how well metronidazole can reduce harmful bacteria in rectal cancer patients who are receiving pre-surgery treatment. Researchers will also observe if metronidazole, when combined with standard treatments, can enhance the body's ability to fight the tumor. Although the benefits of this drug combination are not yet proven, the study aims to offer potential therapeutic advantages, and patients will be closely monitored for any changes in their cancer and overall health.

The study will also look at survival rates and the chances of cancer returning over two years after the study ends. Researchers will compare the tumor responses of patients receiving metronidazole with those from past studies. Additionally, they will explore changes in immune and bacterial cells in tissue samples taken before and after treatment, when available.

Eligibility Criteria

Inclusion Criteria

  • Adults with locally advanced rectal cancer planning to receive total pre-surgery therapy.
  • No previous chemotherapy for the current tumor.
  • Age 18 or older.
  • Good overall health with a performance status score of 2 or less.
  • Adequate organ and bone marrow function, as shown by specific blood tests.
  • If infected with hepatitis B, the virus must be under control with treatment.
  • If previously infected with hepatitis C, the infection must be treated and cured.
  • No distant cancer spread that cannot be removed by surgery.
  • No primary tumors that cannot be removed by surgery.
  • Other cancers that do not interfere with the study are allowed.
  • If there is a history of heart disease, patients must have a good heart function assessment.
  • Women and men must agree to use effective birth control during the study and for a period after.
  • Ability to understand and sign a consent form.
  • Both English and non-English speakers can participate.

Exclusion Criteria

  • Recent chemotherapy or radiation within the past year.
  • Currently taking other experimental drugs.
  • Brain cancer spread or other cancer spread that cannot be surgically removed.
  • Allergic reactions to metronidazole or similar drugs.
  • Taking disulfiram.
  • Having Cockayne syndrome.
  • Uncontrolled health issues.
  • HIV-positive patients on stable treatment with undetectable viral load can participate.
  • Mental health or social issues that prevent following study requirements.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
  • Recent chemotherapy within the last year.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.