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L'essai clinique NCT06223659 pour Mélanome Cutané, Carcinome à Cellules de Merkel, Carcinome épidermoïde cutané est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université d'État de l'OhioEMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers
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L'essai clinique NCT06223659 est conçu pour étudier le treatment de Mélanome Cutané, Carcinome à Cellules de Merkel, Carcinome épidermoïde cutané. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 19 décembre 2023 et vise à recruter 100 participants. Dirigé par l'Université d'État de l'Ohio, l'essai devrait être terminé d'ici le 31 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 6 mars 2025.
Résumé succinct
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.
Description détaillée
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.
Titre officiel
Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers
Conditions
Mélanome CutanéCarcinome à Cellules de MerkelCarcinome épidermoïde cutanéAutres identifiants de l'essai
Numéro NCT
Date de début (réel)
2023-12-19
Dernière mise à jour publiée
2025-03-06
Date de fin (estimée)
2025-12-31
Inscription (estimée)
100
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur placeboCohort 2 (placebo cream) Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure. | Administration de placebo Apply topically to skin Administration de questionnaire Ancillary studies |
ExpérimentalCohort 1 (EMLA cream) Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure. | Eutectic Mixture of Local Anesthetics Apply topically to skin Administration de questionnaire Ancillary studies |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Incidence of adverse events | Reported side effects will be recorded and compared between the two groups using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 30 minutes after lymphoscintigraphy injection |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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.
- 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
Université d'État de l'Ohio455 essais cliniques actifs à explorerPartie responsable de l'essai
Carlo Contreras, Investigateur principal, Principal Investigator, Ohio State University Comprehensive Cancer Center
Contact central de l'essai
Contact: The Ohio State University Comprehensive Cancer Center, 800-293-5066, [email protected]
1 Centres de l'essai dans 1 pays
Ohio
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Carlo M. Contreras, MD, Contact, 614-366-3681, [email protected]
Carlo M. Contreras, MD, Investigateur principal
En recrutement