Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery

Launched by RYAN CAREY · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a local anesthetic called lidocaine, which is commonly used to numb areas during surgery, to see if it can also help fight oropharyngeal cancer. Researchers want to find out if injecting lidocaine directly into the tumor before surgery is safe and if it helps improve treatment outcomes, such as controlling the cancer and extending survival. Participants will be undergoing a procedure called direct laryngoscopy, and if they meet the study criteria, they may receive this injection before having their cancer surgically removed.

To be eligible for the trial, participants must be 18 years or older and have a confirmed diagnosis of oropharyngeal squamous cell carcinoma. They should also be planning to undergo the laryngoscopy as part of their treatment evaluation. Those with certain medical histories or conditions, such as previous radiation treatment for head and neck cancer or uncontrolled health issues, may not be able to participate. If you join the trial, you'll be closely monitored to assess the effects of the lidocaine injection and how it impacts your treatment. It's important to understand the study's nature and potential risks, and you'll have the chance to discuss any questions with the medical team before agreeing to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 18 years older or more.
• • Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.
• • Clinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).
• • Any clinical N stage disease (per AJCC 8th Ed).
• • Patients must be undergoing direct laryngoscopy +/- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.
• • Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.
• • Ability to understand and the willingness to provide written informed consent.
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• Exclusion Criteria:
• • Prior external beam radiation therapy to the head and neck.
• • Prior chemotherapy for head and neck cancer.
• • Tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).
• • Presence of distant metastatic disease.
• • Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
• • Known history of hypersensitivity to lidocaine or other amide local anesthetics.
• • Pregnant or breastfeeding.