RecruitingPhase 1NCT06747390

Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery

A Phase I Randomized Controlled Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Sponsor

Ryan Carey

Enrollment

30 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

Oropharyngeal Cancer Squamous Cell Carcinoma Human Papilloma Virus Oropharyngeal Squamous Cell Carcinoma (OPSCCA)

Summary

Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether injecting a local anesthetic called lidocaine directly into a throat (oropharyngeal) tumor before surgery can help reduce the risk of cancer cells spreading during the procedure. It is being studied in patients scheduled for robotic-assisted throat cancer surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma (a type of cancer) of the throat or neck, confirmed by biopsy - Your cancer is at any stage in the throat (T1 to T4) - You are scheduled for a throat examination and possible robotic surgery at the University of Pennsylvania **You may NOT be eligible if...** - You have previously received radiation therapy to the throat area - You are unable or unwilling to provide written informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLidocaine 1% Injectable Solution

1% lidocaine will be injected under direct visualization (not exceeding the maximum tolerated dose of 4.5 mg/kg body weight) into the primary tumor with the aim to distribute the lidocaine evenly into the tumor.

Locations(1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06747390

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