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Recruiting NCT06223659

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

Phase II Interventional Cutaneous Melanoma Merkel Cell Carcinoma Skin Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eutectic Mixture of Local Anesthetics, Placebo Administration, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Cutaneous Melanoma, Merkel Cell Carcinoma, Skin Squamous Cell Carcinoma. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Eutectic Mixture of Local Anesthetics
    Apply topically to skin
  • Drug Placebo Administration
    Apply topically to skin
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Pain score [Time frame: Up to 1 year]
Secondary outcome measures (1)
  • Incidence of adverse events [Time frame: 30 minutes after lymphoscintigraphy injection]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT06223659 · OSU-23046 · NCI-2023-10465

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗