Clinical trial NCT06223659: EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers
Official title: Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous Melanoma
Merkel Cell Carcinoma
Skin Squamous Cell Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: Up to 1 year
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 30 minutes after lymphoscintigraphy injection
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Carlo M Contreras, MD
role: PRINCIPAL_INVESTIGATOR
References: