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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
Patients applied
Trial Officials
Natalie Lockney, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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