← Back to Search

Antibiotics Before Surgery for Melanoma

Phase 1
Waitlist Available
Led By Emily Z Keung
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
Adult subjects with early stage melanoma (stage I-II)
Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at 2 weeks post-surgery, and 3 months post-surgery
Awards & highlights

Study Summary

This trialstudies how antibiotics affect the microbes in the stomach/intestines before surgery for melanoma. It may help learn if changes in microbes affect surgery & cancer response.

Who is the study for?
This trial is for adults with early stage melanoma (stage I-II) who are scheduled for surgery to remove the cancer. Participants must not have used antibiotics in the last three months, be pregnant, or allergic to beta-lactam/cephalosporin antibiotics. They should not have infections or conditions that increase infection risk.Check my eligibility
What is being tested?
The study is testing how taking the antibiotic cefazolin before surgery affects the microbiome of patients with stage I-II melanoma. Researchers want to see if changes in gut microbes influence recovery and response to cancer treatment.See study design
What are the potential side effects?
Cefazolin may cause side effects like allergic reactions, diarrhea, nausea, rash, and possible changes in gut bacteria which could affect digestion and immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have early stage melanoma (stage I or II).
Select...
I am having surgery to remove a tumor and possibly check nearby lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 2 weeks post-surgery, and 3 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 2 weeks post-surgery, and 3 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in microbiome alpha diversity
Secondary outcome measures
Change in microbiome diversity
Change in relative abundance of microbes
Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines
+1 more

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00096226
93%
Fatigue
81%
Dyspnea
72%
Cough
67%
Hemoglobin
65%
Leukopenia NOS
61%
Nausea
60%
Anorexia
60%
Hyperglycemia NOS
58%
Dysphagia
56%
Esophagitis NOS
53%
Dermatitis radiation NOS
49%
Peripheral sensory neuropathy
46%
Weight decreased
44%
Constipation
44%
Alopecia
39%
Neutrophil count
35%
Pneumonitis NOS
33%
Chest pain
32%
Skin hyperpigmentation
30%
Platelet count decreased
30%
Chest wall pain
28%
Hypoalbuminemia
26%
Hyponatremia
25%
Pleural effusion
25%
Diarrhea NOS
25%
Lymphopenia
23%
Dyspepsia
23%
Vomiting NOS
21%
Aspartate aminotransferase increased
21%
Arthralgia
21%
Insomnia
19%
Sinus tachycardia
19%
Alanine aminotransferase increased
19%
Dehydration
19%
Hypocalcemia
19%
Myalgia
19%
Pain - Other
18%
Atelectasis
18%
Pneumothorax NOS
18%
Pericardial effusion
18%
Supraventricular arrhythmia NOS
18%
Hypokalemia
18%
Pyrexia
18%
Esophageal pain
16%
Blood alkaline phosphatase increased
16%
Hyperkalemia
16%
Dysgeusia
14%
Pharyngolaryngeal pain
14%
Hypomagnesemia
14%
Back pain
14%
Dizziness
14%
Headache
14%
Pruritus
12%
Pulmonary fibrosis
12%
Blood/bone marrow - Other
12%
Dry skin
12%
Sweating increased
12%
Hypersensitivity NOS
11%
Laryngitis NOS
11%
Hypoxia
11%
Radiation recall syndrome
11%
Metabolic/laboratory - Other
11%
Pain in extremity
11%
Dermatitis exfoliative NOS
11%
Depression
11%
Hypotension NOS
9%
Pulmonary/upper respiratory - Other
9%
Blood bilirubin increased
9%
Dry mouth
9%
Stomatitis
9%
Blood creatinine increased
9%
Anxiety
9%
Dermatology/skin - Other
9%
Thrombosis
7%
Hot flushes NOS
7%
Bronchospasm
7%
Edema: limb
7%
Hypermagnesemia
7%
Bone pain
7%
Pollakiuria
7%
Rigors
5%
Rhinitis allergic NOS
5%
Epistaxis
5%
Prolonged chest tube drainage or air leak after pulmonary resection
5%
Vision blurred
5%
Gastritis NOS
5%
Mucositis/stomatitis (functional/symptomatic): Esophagus
5%
Blood bicarbonate decreased
5%
Hypercalcemia
5%
Hypophosphatemia
5%
Ataxia
5%
Muscle weakness NOS
5%
Peripheral motor neuropathy
5%
Confusional state
2%
Colonic obstruction
2%
Arrhythmia NOS
2%
Ocular/visual - Other
2%
Ileus paralytic
2%
Abdominal distention
2%
Myocardial ischemia
2%
Serum sickness
2%
Anal infection NOS
2%
Gingival infection
2%
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
2%
Erythema multiforme
2%
Syncope
2%
Urinary retention
2%
Acute respiratory distress syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation, Surgery, Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (surgical resection)Experimental Treatment1 Intervention
Patients undergo standard of care surgical resection.
Group II: Arm A (cefazolin, surgical resection)Active Control2 Interventions
Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2021
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,761 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
5,053 Patients Enrolled for Cutaneous Melanoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,133 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Emily Z KeungPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
2020. "The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04875728.
All > Microbiome
~9 spots leftby Feb 2027
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