Lidocaine injection before surgery for oropharyngeal cancer
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
This study tests if giving a lidocaine injection before surgery can help improve outcomes for patients with oropharyngeal cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06747390 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed oropharyngeal squamous cell carcinoma who are scheduled for direct laryngoscopy and TORS.
Not a fit: Patients who have received prior radiation or chemotherapy for head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance tumor response and improve survival outcomes for patients with oropharyngeal cancer.
How similar studies have performed: While the use of lidocaine in this context is novel, similar studies exploring local anesthetics for anticancer effects have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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. \--- 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 this trial is running
Philadelphia, Pennsylvania
- 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
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.