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

February 22, 2024 updated by: Natalie Lockney

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vanderbilt-Ingram Service for Timely Access
  • Phone Number: 800-811-8480
  • Email: cip@vumc.org

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
          • Vanderbilt-Ingram Service for Timely Access
          • Phone Number: 800-811-8480
          • Email: cip@vumc.org
        • Principal Investigator:
          • Natalie Lockney, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin plus Ketamine
Gabapentin and Ketamine will be taken 3 times per day.
Drug: Gabapentin
Taken by mouth 3 times per day
Other Names:
  • Neurontin
Drug: Ketamine
Administered intranasally 3 times per day
Other Names:
  • Ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to a maximum planned dose of 40 mg three times a day
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)
Number of Participants With Grade 3 or 4 Adverse Events
Up to 30 post-treatment (Phase II)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natalie Lockney

Investigators

  • Principal Investigator: Natalie Lockney, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC HNP 2173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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