The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04875728
Collaborator
National Cancer Institute (NCI) (NIH)
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Study Details

Study Description

Brief Summary

This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.

Detailed Description

PRIMARY OBJECTIVE:
  1. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.
SECONDARY OBJECTIVES:
  1. To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.

  2. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.

ARM B: Patients undergo standard of care surgical resection.

After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
Actual Study Start Date :
Sep 8, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A (cefazolin, surgical resection)

Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.

Drug: Cefazolin
Given IV

Procedure: Resection
Undergo standard of care surgical resection
Other Names:
  • Surgical Resection
  • Experimental: Arm B (surgical resection)

    Patients undergo standard of care surgical resection.

    Procedure: Resection
    Undergo standard of care surgical resection
    Other Names:
  • Surgical Resection
  • Outcome Measures

    Primary Outcome Measures

    1. Change in microbiome alpha diversity [Baseline up to 2 weeks post-surgery]

      The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.

    Secondary Outcome Measures

    1. Change in relative abundance of microbes [Baseline, at 2 weeks post-surgery, and 3 months post-surgery]

    2. Change in microbiome diversity [Baseline up to 3 months post-surgery]

      The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.

    3. Wound (surgical site) infection rate [Up to 3 months post-surgery]

    4. Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines [Up to 3 months post-surgery]

      By analysis of composition of circulating immune cell populations and cytokines.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult subjects with early stage melanoma (stage I-II)

    • Patients must be undergoing wide local excision +/- sentinel lymph node biopsy

    • Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

    Exclusion Criteria:
    • Use of antibiotics within the three months prior to surgery

    • Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics

    • Presence of an infection at the time of surgery

    • Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI)

    • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration

    • American Society of Anesthesiologists (ASA) grade > IV

    • Refusal to participate in the study

    • Patients who are pregnant will not be included in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Emily Z Keung, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04875728
    Other Study ID Numbers:
    • 2020-0265
    • NCI-2020-07071
    • 2020-0265
    First Posted:
    May 6, 2021
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 28, 2022