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

NCT06223659 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-23046NCI-2023-10465
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Melanoma; Merkel Cell Carcinoma; Skin Squamous Cell Carcinoma

Outcome Measures

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.

  Up to 1 year

Secondary Outcomes (1)

• Incidence of adverse events

  30 minutes after lymphoscintigraphy injection

Study Arms (2)

Cohort 2 (placebo cream)

PLACEBO COMPARATOR

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

Drug: Placebo Administration; Other: Questionnaire Administration

Cohort 1 (EMLA cream)

EXPERIMENTAL

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

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

Interventions

Eutectic Mixture of Local Anesthetics DRUG

Apply topically to skin

Also known as: EMLA, Lidocaine-Prilocaine Eutectic Mixture, Lidocaine/Prilocaine, Oraqix

Cohort 1 (EMLA cream)

Placebo Administration DRUG

Apply topically to skin

Cohort 2 (placebo cream)

Questionnaire Administration OTHER

Ancillary studies

Cohort 1 (EMLA cream); Cohort 2 (placebo cream)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biologic males or females
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Melanoma; Carcinoma, Merkel Cell

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Carlo M Contreras, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 25, 2024
• Study Start: December 19, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)