Using EMLA cream to reduce pain during lymphoscintigraphy for skin cancer
Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers
This study is testing if EMLA cream can help reduce pain for patients getting injections during a lymphoscintigraphy procedure for skin cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06223659 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of EMLA topical cream in alleviating pain for patients undergoing Technetium 99 injections as part of a lymphoscintigraphy procedure for skin cancers. Participants are randomized into two groups: one receiving EMLA cream and the other receiving a placebo, both applied 30 minutes prior to the procedure. The study aims to determine if EMLA can significantly reduce the pain associated with the injections, which are necessary for identifying lymph nodes affected by cancer. This is the first investigation of EMLA cream's efficacy in this specific context, building on previous findings in breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 with confirmed diagnoses of cutaneous melanoma, Merkel cell carcinoma, or skin squamous cell carcinoma requiring lymphoscintigraphy.
Not a fit: Patients with known allergies to EMLA cream or local anesthetics, chronic pain conditions, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more comfortable experience for patients undergoing lymphoscintigraphy for skin cancer.
How similar studies have performed: Previous studies have shown EMLA cream to be effective in reducing pain in other contexts, but this specific application for lymphoscintigraphy is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Carlo M Contreras, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.