Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Overview
This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.
Detailed Description
Objectives:
* To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day.
* To evaluate feasibility and tolerability
Exploratory:
- To assess pain, symptom burden, functionality, and quality of life
Who Can Participate
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
Disclaimer
This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.
Participation decisions can be made only after review by the study team and your treating clinician.