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

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

NCT ID: NCT06223659

Condition: Cutaneous Melanoma
Merkel Cell Carcinoma
Skin Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Lidocaine
Anesthetics, Local
Prilocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: Eutectic Mixture of Local Anesthetics
Description: Apply topically to skin
Arm group label: Cohort 1 (EMLA cream)

Other name: EMLA

Other name: Lidocaine-Prilocaine Eutectic Mixture

Other name: Lidocaine/Prilocaine

Other name: Oraqix

Intervention type: Drug
Intervention name: Placebo Administration
Description: Apply topically to skin
Arm group label: Cohort 2 (placebo cream)

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Cohort 1 (EMLA cream)
Arm group label: Cohort 2 (placebo cream)

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ohio State University Comprehensive Cancer Center

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Contact:
Last name: Carlo M. Contreras, MD

Phone: 614-366-3681
Email: Carlo.Contreras@osumc.edu

Investigator:
Last name: Carlo M. Contreras, MD
Email: Principal Investigator

Start date: December 19, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Ohio State University Comprehensive Cancer Center
Agency class: Other

Source: Ohio State University Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06223659
http://cancer.osu.edu