EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06223659
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cutaneous Melanoma
  • Merkel Cell Carcinoma
  • Skin Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Eutectic Mixture of Local Anesthetics — DRUG
    Apply topically to skin
  • Placebo Administration — DRUG
    Apply topically to skin
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial tests how well EMLA topical cream works in treating pain in patients with skin cancers receiving Technetium 99 injections for a lymphoscintigraphy mapping procedure. A lymphoscintigraphy mapping procedure is used to find the main or lead lymph node (tissue that fight infection) so it can be removed and checked for tumor cells. Using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients. The Technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin. The EMLA topical cream, which contains a numbing medicine to block pain from nerve endings, has been studied in breast cancer patients with a difference in pain reported, but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer. This study may help researchers learn whether the use of EMLA cream may improve the associated pain at the time of the lymphoscintigraphy procedure.

Key Dates

Start date
Dec 19, 2023
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Cohort 2 (placebo cream)
    Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.
  • Experimental: Cohort 1 (EMLA cream)
    Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Primary Outcome Measure

Pain score [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Carlo M. Contreras, MD
[email protected]
614-366-3681
Carlo M. Contreras, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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