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Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer

ConditionsOral Squamous Cell CarcinomaOral CancerHead and Neck CancerHead and Neck Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed squamous cell carcinoma of the oral cavity

Must have planned surgery for curative intent

Participants ≥ 18 years of age

Participants must have the ability to understand and the willingness to sign a written informed consent document

Disqualifiers

Known allergy to metronidazole and/or chlorhexidine

Severe liver or kidney disease as determined by history of laboratory tests

Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)

Recurrent oral cancer after prior radiation or chemoradiation

Trial design

Design model

Single group

Treatments tested in this trial

  • Metronidazole

    Drug

    Participants will receive metronidazole (500 mg t.i.d. x 10 days)

  • Chlorhexidine

    Other intervention

    Mouth rinse chlorhexidine (10 ml t.i.d. x 10 days)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: 10 days of metronidazole and chlorhexidineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in absolute amount of intraumoral bacteria as quantified by 16S rRNA qPCR

The difference between pre-treatment and post-treatment tumor bacteria burden will be assessed.

Time frame
Baseline, surgery (10 days post intervention)

Secondary outcomes

1

Change in absolute amount of intraumoral bacteria in post treatment participants compared to control patients as quantified by 16S rRNA qPCR

Time frame
Baseline, surgery (10 days post intervention)
2

Disease-free survival

Time frame
Time from date of randomization to recurrence, second primary malignancy, or death, as determined by standard of care surveillance, up to three years.
3

Overall Survival

Time frame
Time from date of randomization to recurrence, second primary malignancy, or death, as determined by standard of care surveillance, up to three years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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