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

Sponsor
Natalie Lockney (Other)
Overall Status
Recruiting
CT.gov ID
NCT05156060
Collaborator
(none)
44
Enrollment
1
Location
1
Arm
47.2
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 24, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0) [Approximately 28 days (Phase I)]

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

    2. Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0) [Up to 30 post-treatment (Phase II)]

      Number of Participants With Grade 3 or 4 Adverse Events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Natalie Lockney

    Investigators

    • Principal Investigator: Dianne Lou, MD, PhD, Vanderbilt-Ingram Cancer Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Natalie Lockney, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05156060
    Other Study ID Numbers:
    • VICC HNP 2173
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Chronic Pain
    Ketamine
    Gabapentin

    Study Results

    No Results Posted as of Mar 4, 2022