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RecruitingNCT05156060Updated Oct 21, 2024

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

A Phase 1/2 interventional study of Gabapentin and Ketamine in Head and Neck Cancer and Locally Advanced Head and Neck Carcinoma, sponsored by Natalie Lockney. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-10-21.

Sponsored by Natalie Lockney · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 8 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

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.

Read the detailed 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
02

Conditions studied

  • Head and Neck Cancer
  • Locally Advanced Head and Neck Carcinoma
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 64 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

This is the only study on the registry with Natalie Lockney as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Gabapentin plus Ketamine

    Gabapentin and Ketamine will be taken 3 times per day.

    Drug: Gabapentin · Drug: Ketamine

Interventions

  • DrugGabapentin

    Taken by mouth 3 times per day

    Also known as: Neurontin

  • DrugKetamine

    Administered intranasally 3 times per day

    Also known as: Ketalar

06

What researchers measure

Primary outcomes

  1. Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)

    Up to a maximum planned dose of 40 mg three times a day

    Time frame: Approximately 28 days (Phase I)

  2. Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)

    Number of Participants With Grade 3 or 4 Adverse Events

    Time frame: Up to 30 post-treatment (Phase II)

07

Study locations

1 of 1 sites recruiting
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232, United States
    • Vanderbilt-Ingram Service for Timely Access · Contact · cip@vumc.org · 800-811-8480
    • Natalie Lockney, MD · Principal investigator
    Recruiting
08

References and documents

Study documents

  • Informed consent form · Aug 22, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05156060
Lead sponsor
Natalie Lockney
Responsible party
Natalie Lockney (Sponsor Investigator, Vanderbilt-Ingram Cancer Center) — Sponsor-investigator
First posted
Dec 14, 2021
Start date
Jan 24, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 21, 2024

Study contacts

Vanderbilt-Ingram Service for Timely Access
Contact
cip@vumc.org
800-811-8480
Natalie Lockney, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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