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EMLA Cream for Pain in Skin Cancer
Phase 2
Recruiting
Led By Carlo M Contreras, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed cutaneous melanoma, Merkel cell carcinoma, squamous cell carcinoma, or other cutaneous malignancy for which lymphoscintigraphy and sentinel lymph node biopsy has been recommended.
Be older than 18 years old
Must not have
Contraindication to Tc99 injection for sentinel lymph node mapping
Mucosal or genital lymphoscintigraphy site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Summary
This trial is testing how well a cream called EMLA works in reducing pain in patients with skin cancers who are receiving Technetium 99 injections for a procedure called lymphoscintigraphy mapping.
Who is the study for?
This trial is for patients with skin cancers like Squamous Cell Carcinoma and Merkel Cell Carcinoma, who are undergoing a lymphoscintigraphy mapping procedure using Technetium 99 injections. The study aims to include those who need their lead lymph node identified and possibly removed.
What is being tested?
The trial is testing EMLA topical cream, which contains numbing medicine, against a placebo to see if it reduces pain from the injections during the lymphoscintigraphy procedure in skin cancer patients.
What are the potential side effects?
Potential side effects of EMLA cream may include reactions at the application site such as redness, swelling or itching. Systemic side effects are rare but could involve nervous system or blood-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a skin cancer diagnosis that requires a special lymph node biopsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have a Tc99 injection for lymph node mapping due to health reasons.
Select...
I have had a lymph scan of my mucosal or genital area.
Select...
I am unable to give consent on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain score
Secondary study objectives
Incidence of adverse events
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 1 (EMLA cream)Experimental Treatment2 Interventions
Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.
Group II: Cohort 2 (placebo cream)Placebo Group2 Interventions
Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.
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Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
294,395 Total Patients Enrolled
Carlo M Contreras, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
115 Total Patients Enrolled
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