RECRUITING

Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-20
Study Completion:2028-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06747390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ryan Carey, MD
CONTACT
2156622777
ryan.carey@pennmedicine.upenn.edu
Prannda Sharma, MS
CONTACT
pranndas@pennmedicine.upenn.edu

Principal Investigator

Ryan Carey, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Ryan Carey

  • Ryan Carey, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-20
Study Completion Date2028-11-01

Study Record Updates

Study Start Date2025-01-20
Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

  • TransOral Robotic Surgery (TORS)
  • Oropharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Cancer
  • Human Papilloma Virus
  • Squamous Cell Carcinoma
  • Lidocaine

Additional Relevant MeSH Terms

  • Oropharyngeal Squamous Cell Carcinoma (OPSCCA)
  • Oropharyngeal Cancer
  • Human Papilloma Virus
  • Squamous Cell Carcinoma