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RecruitingPhase 1Phase 2NCT05156060

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

Sponsor

Natalie Lockney

Enrollment

64 participants

Start Date

Jan 24, 2022

Study Type

INTERVENTIONAL

Conditions

Head and Neck CancerLocally Advanced Head and Neck Carcinoma

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

Min Age: 21 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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

DRUGGabapentin

Taken by mouth 3 times per day

DRUGKetamine

Administered intranasally 3 times per day

Locations(1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

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NCT05156060

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