Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Infections

Rare Diseases

Carcinoma

Melanoma

Skin Neoplasms

Carcinoma, Squamous Cell

Pain

Melanoma, Cutaneous Malignant

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Adenocarcinoma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Anesthetics

Anesthetics, Local

Prilocaine

Lidocaine, Prilocaine Drug Combination

Sodium Channel Blockers

Diuretics, Potassium Sparing

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

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

Eutectic Mixture of Local Anesthetics

Placebo Administration

Questionnaire Administration

The Ohio State University Comprehensive Cancer Center

Carlo M. Contreras, MD

Carlo M Contreras, MD

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.

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.

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

Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers

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.

Reported side effects will be recorded and compared between the two groups using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers	NCT06223659	Cutaneous Melan... Merkel Cell Car... Skin Squamous C...	Eutectic Mixtur... Placebo Adminis... Questionnaire A...	18 Years - 99 Years	Ohio State University Comprehensive Cancer Center
EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers	NCT06223659	Cutaneous Melan... Merkel Cell Car... Skin Squamous C...	Eutectic Mixtur... Placebo Adminis... Questionnaire A...	18 Years - 99 Years	Ohio State University Comprehensive Cancer Center

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