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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorOhio State University Comprehensive Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Eutectic Mixture of Local Anesthetics

    Drug

    Apply topically to skin

  • Placebo Administration

    Drug

    Apply topically to skin

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Cohort 2 (placebo cream)Placebo comparator 2 interventions
Group B: Cohort 1 (EMLA cream)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 year

Secondary outcomes

1

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.

Time frame
30 minutes after lymphoscintigraphy injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.