ClinConnect ClinConnect Logo
Search / Trial NCT05156060

Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer

Launched by NATALIE LOCKNEY · Nov 30, 2021

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of two medications, gabapentin and ketamine, to help prevent or treat pain in patients with locally advanced head and neck cancer who are receiving radiation therapy or chemotherapy. The goal of the study is to find a safe and effective dose of this medication combination. Researchers are currently looking for participants who are 21 years or older, have been diagnosed with head and neck cancer that has not spread to other areas, and are able to speak English. Eligible participants should be able to provide informed consent and have a good performance status, meaning they can carry out daily activities with little difficulty.

If you join this trial, you will receive the study medication and be monitored closely by the medical team to ensure your safety. However, if you have already used gabapentin or ketamine, have certain medical conditions, or cannot take ketamine in a specific way, you may not be eligible. This study is important because it aims to improve pain management for patients undergoing treatment for head and neck cancer, which can significantly affect their quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Histologically proven cancer of the head and neck cancer
  • Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)
  • Planned primary or adjuvant radiation or chemoradiation therapy
  • Willing and able to provide informed consent
  • ECOG PS 0-2
  • Age ≥ 21 years
  • English speaking
  • Exclusion Criteria:
  • Currently on gabapentin or ketamine
  • Prior non-tolerance of gabapentin or ketamine
  • Unable to administer ketamine intranasally due to anatomical restrictions
  • History of seizure disorder
  • History of schizophrenia
  • History of increased intracranial pressure
  • Glomerular filtration rate \<30 mL/min/1.73 m2

About Natalie Lockney

Natalie Lockney is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapies and a collaborative approach, she oversees the planning, execution, and management of clinical trials across various therapeutic areas. Her expertise in regulatory compliance, patient recruitment, and data integrity ensures that trials are conducted efficiently and ethically. Through her leadership, Natalie fosters partnerships with research institutions, healthcare professionals, and stakeholders to drive scientific discovery and bring new treatments to market.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Natalie Lockney, MD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials