Lidocaine injection before surgery for oropharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial evaluates the safety and efficacy of intratumoral lidocaine injection in patients with oropharyngeal squamous cell carcinoma undergoing TransOral Robotic Surgery (TORS). Participants will be randomly assigned to receive either a lidocaine injection or no injection during direct laryngoscopy prior to surgery. The study aims to assess the impact of lidocaine on tumor response and various survival metrics, including locoregional control and overall survival. Blood samples will be collected to analyze potential biological effects of the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Abramson Cancer Center at University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Ryan Carey, MD — University of Pennsylvania
• Study coordinator: Ryan Carey, MD
• Email: ryan.carey@pennmedicine.upenn.edu
• Phone: 2156622777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.