Gabapentin plus Ketamine for the Prevention of Acute and Chronic Pain in Patients with Locally Advanced Head and Neck Cancer Undergoing Chemoradiation
Gabapentin plus Ketamine for the Prevention of Acute and Chronic Pain in Patients with Locally Advanced Head and Neck Cancer Undergoing Chemoradiation
This phase I/II trial studies the side effects and best dose of a combination of gabapentin and ketamine and to see how well it works to prevent acute and chronic pain in patients receiving chemotherapy and radiation therapy (chemoradiation) for head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced). Gabapentin is a medication that is commonly used to treat nerve related pain. Specifically, it has been used to treat pain involving the mouth, throat and nasal passages in head and neck cancer patients treated with radiation. Ketamine is a type of general anesthetic that blocks pathways to the brain involved with sensing pain. This trial may help doctors determine how patients tolerate the combination of gabapentin and ketamine and to find the correct dosing for ketamine in those taking gabapentin. This will be the basis for a future, larger study to look at how effective this combination is at reducing and/or preventing pain in head and neck cancer patients.
Head/Neck,
Phase I
Phase I/II
Adults
Not Available
Not Available
Lockney, Natalie
Local
Vanderbilt University
01-11-2022
Eligibility
21 Years
BOTH
NO
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
Eastern Cooperative Oncology Group (ECOG) performance status (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 m^2
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
Eastern Cooperative Oncology Group (ECOG) performance status (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 m^2
