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Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
RECRUITINGPhase 1/2Sponsored by Natalie Lockney
Actively Recruiting
PhasePhase 1/2
SponsorNatalie Lockney
Started2022-01-24
Est. completion2025-12-31
Eligibility
Age21 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05156060
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.
Eligibility
Age: 21 Years+Healthy volunteers accepted
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
Conditions3
CancerHead and Neck CancerLocally Advanced Head and Neck Carcinoma
Interventions2
Locations1 site
Vanderbilt-Ingram Cancer Center
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Actively Recruiting
PhasePhase 1/2
SponsorNatalie Lockney
Started2022-01-24
Est. completion2025-12-31
Eligibility
Age21 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05156060