Lidocaine induces apoptosis in head and neck squamous cell carcinoma through activation of bitter taste receptor T2R14.
Zoey A Miller, Arielle Mueller, TaeBeom Kim...
https://pubmed.ncbi.nlm.nih.gov/37995679Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06747390
Intratumoral Lidocaine Injection Before Transoral Robotic Surgery and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Led by Ryan Carey · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating intratumoral lidocaine injection for patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) undergoing surgery. This phase I randomized controlled trial aims to determine if injecting 1% lidocaine into the tumor before TransOral Robotic Surgery (TORS) and neck dissection is safe and causes a major pathologic treatment effect. The study will also investigate whether lidocaine injection improves locoregional control, progression-free survival, metastasis-free survival, and overall survival compared to no injection. Participants will be randomly assigned to receive either an intratumoral injection of 1% lidocaine or no injection at the time of direct laryngoscopy under general anesthesia. The lidocaine dose will not exceed 4.5 mg/kg body weight and will be injected directly into the primary tumor. After the study intervention, patients will receive standard care, which may include surgery (TORS with neck dissection) or radiation therapy, with or without chemotherapy. Blood samples will be collected before and after the intervention to monitor effects. During the trial, researchers will assess safety by monitoring adverse events and evaluate the pathological tumor response in surgical specimens. Tumor response will be measured by the area of pathologic change in the tumor tissue. Patients not proceeding to surgery or found to have non-HPV OPSCC pathology will not be included in the primary analysis. The study aims to enroll 30 evaluable patients, with follow-up for up to two years to assess tumor control and survival outcomes.
CONDITIONS
Brief Title
Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older.
- Histologically confirmed squamous cell carcinoma of the oropharynx or neck.
- Clinical T1, T2, T3, or T4 stage oropharyngeal disease.
- Any clinical N stage disease.
- Scheduled for direct laryngoscopy with or without biopsy as part of work-up for definitive TransOral Robotic Surgery and selective neck dissection.
- Ability and willingness to provide written informed consent indicating awareness of investigational treatment and potential risks and benefits.
You will not qualify if you...
- Prior external beam radiation therapy to the head and neck.
- Prior chemotherapy for head and neck cancer.
- Tumor invasion of lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, skull base, or encasement of carotid artery.
- Presence of distant metastatic disease.
- Uncontrolled inter-current illnesses such as symptomatic congestive heart failure, unstable angina, connective tissue disease, or psychiatric illness/social situations limiting study compliance.
- Known hypersensitivity to lidocaine or other amide local anesthetics.
- Pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for direct laryngoscopy and biopsy
Treatment
Duration - Surgery and immediate treatment period
Participants receive intratumoral injection of 1% lidocaine or no injection at the time of direct laryngoscopy prior to surgery. This is followed by standard surgery including TransOral Robotic Surgery and neck dissection.
1 treatment visit (in-person) for injection and surgery
Follow-up
Duration - Up to 2 years
Participants are monitored for safety and cancer outcomes including adverse events, tumor response, and survival for up to 2 years after surgery.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
R
Ryan Carey, MD
P
Prannda Sharma, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
T2R bitter taste receptors regulate apoptosis and may be associated with survival in head and neck squamous cell carcinoma.
Ryan M Carey, Derek B McMahon, Zoey A Miller...
https://pubmed.ncbi.nlm.nih.gov/34717036Effect of Peritumoral Infiltration of Local Anesthetic Before Surgery on Survival in Early Breast Cancer.
Rajendra A Badwe, Vani Parmar, Nita Nair...
https://pubmed.ncbi.nlm.nih.gov/37023374