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NCT Number: NCT05156060

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

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.

Recruiting

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Locally Advanced Head and Neck Carcinoma Neoplasms Neoplasms by Site

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Natalie Lockney, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Taken by mouth 3 times per day

Other names: Neurontin

ketamine

Drug

Administered intranasally 3 times per day

Other names: Ketalar

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

Sponsors and collaborators

Lead sponsor

Natalie Lockney

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 14, 2021
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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