About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biologic males or females
18 - 99 years of age
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.
Disqualifiers
Known allergy or intolerance to EMLA cream, lidocaine, prilocaine, or any other local anesthetic
History of adhesive allergy
Contraindication to Tc99 injection for sentinel lymph node mapping
Incarcerated patients
Trial design
Parallel
Treatments tested in this trial
Eutectic Mixture of Local Anesthetics
DrugApply topically to skin
Placebo Administration
DrugApply topically to skin
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Pain score
Pain will be measured on a Defense and Veterans Pain Rating 10-point scale where 1 is the lowest measure of pain, and 10 is the highest pain. Will be analyzed using an independent samples t-test to compare the mean pain score of the two cohorts. Descriptive statistics of patient demographics and adverse events will also be reported.
Secondary outcomes
Incidence of adverse events
Reported side effects will be recorded and compared between the two groups using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Sponsors and contacts
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