Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Ryan Carey
Study ID
NCT06747390
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine 1% Injectable Solution — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 23, 2025
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Arm - No Injection
    No injection at the time of direct laryngoscopy.
  • Experimental: Lidocaine Injectible product
    Intratumoral injection of 1% lidocaine at the time of direct laryngoscopy.

Primary Outcome Measure

Safety measured by occurrence of adverse events. [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center at University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Head and neck cancerSkin cancer
By specialty
OncologyENTSkin cancerDermatology
By research site
Abramson Cancer Center at University of Pennsylvania· Philadelphia, PA

Related Studies