NCT05156060PHASE1, PHASE2Recruiting

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

Natalie Lockney

Start Date

1/24/2022

Completion Date

12/31/2026

Summary

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

Eligibility Criteria

Age Range: 21 years to No maximum

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

Interventions

DRUG

Gabapentin

DRUG

Ketamine

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Conditions

Head and Neck CancerLocally Advanced Head and Neck Carcinoma

Locations

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee 37232

United States