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

The Ohio State University

Status and phase: Enrolling; Phase 2

Conditions: Skin Squamous Cell Carcinoma; Merkel Cell Carcinoma; Cutaneous Melanoma

Treatments: Drug: Eutectic Mixture of Local Anesthetics; Other: Questionnaire Administration; Drug: Placebo Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06223659

NCI-2023-10465 (Registry Identifier)

OSU-23046

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. Evaluate if the application of eutectic mixture of local anesthetics (EMLA) topical cream (2.5% lidocaine mixed with 2.5% prilocaine) prior to intra-dermal Technetium 99 sulfur colloid (Tc99 injection) for lymphoscintigraphy can improve associated pain.

OUTLINE: Patients are randomized to 1 of 2 cohorts.

COHORT 1: Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

COHORT 2: Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Patients incapable of independently providing consent
• Mucosal or genital lymphoscintigraphy site
• Pregnancy
• Participant self-declared or Ohio State University (OSU) medical chart listing chronic pain as a pre-existing diagnosis
• Participants with chronic pain as defined by the Centers for Disease Control and Prevention (CDC):"pain lasting 3 months or more that can be caused by a disease or condition, injury, medical treatment, or unknown reason" excluding those with stable co-morbid conditions such as peripheral neuropathy, fibromyalgia, arthritis, and cancer-related pain who do not require narcotics. Patients who require narcotics at any time within the 7-day period leading up to the procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

Cohort 2 (placebo cream)

Placebo Comparator group

Description:

Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Treatment:

Drug: Placebo Administration

Other: Questionnaire Administration

Cohort 1 (EMLA cream)

Experimental group

Description:

Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Treatment:

Other: Questionnaire Administration

Drug: Eutectic Mixture of Local Anesthetics