NCT05156060 Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
| NCT ID | NCT05156060 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Natalie Lockney |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2022-01-24 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief 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 Criteria
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
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