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

Last updated: October 17, 2024
Sponsor: Natalie Lockney
Overall Status: Active - Recruiting

Phase

1/2

Condition

Chronic Pain

Nasopharyngeal Cancer

Head And Neck Cancer

Treatment

Ketamine

Gabapentin

Clinical Study ID

NCT05156060
VICC HNP 2173
  • Ages > 21
  • All Genders

Study 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

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

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

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Ketamine
Phase: 1/2
Study Start date:
January 24, 2022
Estimated Completion Date:
December 31, 2026

Study 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

Connect with a study center

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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