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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - ECOG PS 0-2 - Age ≥ 21 years - English speaking Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Gabapentin

Taken by mouth 3 times per day

DRUG

Ketamine

Administered intranasally 3 times per day

Locations (1)

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States