Recruiting
Phase 1
Phase 2

Gabapentin & Ketamine

Sponsor:

Natalie Lockney

Code:

NCT05156060

Conditions

Head and Neck Cancer

Locally Advanced Head and Neck Carcinoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Gabapentin

Ketamine

Study Details

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.

Conditions

Head and Neck Cancer

Locally Advanced Head and Neck Carcinoma

Study ID

NCT05156060

Start date

Jan 24, 2022

Status verified date

Oct, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not 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

Study Design

Enrollment

64 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gabapentin plus Ketamine

Gabapentin and Ketamine will be taken 3 times per day.

Interventions

Gabapentin

Taken by mouth 3 times per day

Ketamine

Administered intranasally 3 times per day

Primary outcome measure

  • Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0) [ Time Frame: Approximately 28 days (Phase I) ]
  • Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0) [ Time Frame: Up to 30 post-treatment (Phase II) ]

Central Contacts and Locations

Central contacts

Vanderbilt-Ingram Service for Timely Access

800-811-8480cip@vumc.org

Locations

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Service for Timely Access

800-811-8480cip@vumc.org

Principal Investigator:

Natalie Lockney, MD

More Information

Sponsor

Natalie Lockney

Last update posted

Oct 21, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Natalie Lockney on 2024-10-21.