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.
Additional locations may be listed on ClinicalTrials.gov for NCT05156060.
Locations matching your search criteria
United States
Tennessee
Nashville
Vanderbilt University/Ingram Cancer CenterStatus: Active
Contact: Natalie Ausborn Lockney
Phone: 615-322-4967
PRIMARY OBJECTIVE:
I. To establish maximum tolerated dose (MTD) of ketamine in combination with gabapentin up to a maximum planned dose (MPD) of 40 mg three times a day (TID).
SECONDARY OBJECTIVES:
I. Phase II expansion of MTD/MPD as determined through Primary Objective I.
II. An additional 40 patients will be treated at the MTD/MPD to confirm feasibility and to garner additional toxicity data.
EXPLORATORY OBJECTIVES:
I. All participants will complete patient reported outcomes (PROs) that capture pain, symptom burden, functionality, and quality of life.
II. In addition, blood will be collected from subjects and processed for deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and plasma for genomic, transcriptomic, and proteomic studies.
OUTLINE: This is a phase I, dose-escalation study of gabapentin and ketamine followed by a phase II study.
Patients receive gabapentin orally (PO) or via percutaneous endoscopic gastrostomy (PEG) tube three times daily (TID) and ketamine intranasally (IN) TID. Treatment continues until completion of standard chemoradiation therapy (5-7 weeks). Patients also undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up once a month for 3 months.
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorNatalie Ausborn Lockney
